PHSL Newsletters

Coronavirus Preparation Tips

The novel Coronavirus (COVID-19) pandemic is occurring during a time that overlaps with cold and flu season, as well as seasonal allergies. For mild illnesses, including those associated with Coronavirus, supportive care may be the best option. PHSL recommends keeping the following items on hand in case your household is impacted by illness. Many of these items can be purchased at your local pharmacy, grocery store, retailer, or online, which may provide an option for delivery.

Over-the-counter (OTC) medications for symptomatic treatment of respiratory illnesses include:

  • Tylenol (acetaminophen) for fever and aches
  • Mucinex (guaifenesin) to loosen chest congestion
  • Robitussin DM (dextromethorphan) or Delsym for cough
  • Sudafed (pseudoephedrine) or Sudafed PE (phenylephrine) for head congestion

Parents should ensure that they have an adequate amount of infant or children’s strength Tylenol (acetaminophen) and cough medicine. Parents or caregivers should consult a physician before using cough and cold medicine in children under 6 years of age. Also consider keeping alternative remedies, such as honey, for sore throat and saline drops for nasal congestion on hand.

Having a humidifier to run in the room while asleep will increase moisture in the air and may help with cold and respiratory symptoms.  Vick’s VapoRub or equivalent vaporizing rub ointments that contain camphor, eucalyptus oil and menthol can also be beneficial. Additional supplies to keep on hand include a thermometer, tissues, and drinks containing electrolytes, such as Gatorade or Pedialyte, to prevent dehydration. If your local retailer does not have electrolyte solutions available, the World Health Organization (WHO) recommends the following combination to create your own: one level teaspoon of salt, eight level teaspoons of sugar, one liter of clean drinking or boiled water and then cooled.

In addition to OTC medications and supplies for supportive care, you may want to consider purchasing the following items so you do not run out in a time of isolation:

Being prepared during this time is the best way to care for yourself and those around you. If you are uncertain if your illness requires additional treatment, always contact your healthcare provider or utilize telehealth services for assistance.

 

Posted March 20, 2020

2020 Spring Newsletter:

Key Questions and Answers about Ibuprofen Use for COVID-19

COVID-19 have you Quarantined? – Weekend Activities for your To-Do List

Market Effects from COVID-19

Market Effects from COVID-19

Prescription volume dispensed by retail and mail service pharmacies has increased dramatically in March as a result of COVID-19 concerns.  It is common knowledge that the first week of the month is the busiest in retail pharmacy departments.  Medicare checks are received by seniors and updates are made to the Medicaid eligibility files, leading more patients to obtain their needed prescription medications.  This is what pharmacies experienced the week of March 1 to 7.  However, instead of the normal drop-off the week of March 8 to 14, we are aware of pharmacy dispensing volume being 5 to 10% greater than the first week in March.

In a Reuters report published in U.S. News & World Report on March 13th, it was noted that doctors, insurers, and the CDC were urging patients, especially those with chronic conditions, to get enough medicine to last a long period.  Insurers were recommending patients that typically receive only a 30-day supply of their medications talk to their pharmacist, and if needed, their doctor, about getting a 90-day supply. Some insurers were allowing early refills of prescriptions to accommodate their patients’ needs.  All of this created the spike in prescription volume seen in the second week of March.

The increase in prescription volume will lead to an increased demand for prescription drugs and PBM services.  The increased demand will likely create strains on resources, both product materials for manufacturers and services via PBMs.  We believe that this will also lead to an increase in adherence measures, as calculations may be artificially inflated due to early refills and 90 days supply prescriptions.

Will there be a drop in prescription demand when this pandemic is over?   We suspect that patients will increase the days’ supply that they keep on hand, leading to a “new normal” for consumers.

All of this has put more pressure on suppliers to keep more product on hand, for manufacturers to ramp up production, and for raw material suppliers to keep up with demand.  This will require close monitoring in upcoming weeks and months.  The most important thing our industry can do right now is to try to keep up with patient needs and ensure that those in greatest need have access to the supplies they require and medications they take.

In the end, there will be much to learn from this crisis.  Governments, manufacturers, health-care systems, and retailers (not just pharmacies), will all need to look back on the lessons learned to devise and implement processes and procedures to put in place, should we ever encounter something like COVID-19 again.  Furthermore, entities in each of these sectors should work together to develop best practices that are in harmony and will ultimately promote and provide the best patient care and outcomes possible.

Finally, best wishes to all of those on the frontline in healthcare– they are our heroes in this fight against this virus.  It is for their sake that steps are taken to ensure that the supplies and medications needed are always available.

 

Posted March 20, 2020

2020 Spring Newsletter:

Coronavirus Preparation Tips

Key Questions and Answers about Ibuprofen Use for COVID-19

COVID-19 have you Quarantined? – Weekend Activities for your To-Do List

COVID-19 have you Quarantined? – Weekend Activities for your To-Do List

As millions of Americans quarantine themselves in their homes, numerous sources have touted “fun activities you can do at home” and “10 ways to spend the weekend indoors”.  Instead, what about crossing a few forgotten items off your to-do list?  PHSL has five ideas for you to improve your health and increase your sense of accomplishment by checking another item off your list.

  1. Clean out your Medicine Cabinet – When is the last time you’ve cleaned out your medicine cabinet and removed expired OTC medications and unused prescriptions? As you’re thinking about purchasing supplies for a prolonged quarantine, it is important to first inventory the products you have on hand to determine what you actually need.  In order to ensure everyone gets the medications they need, it’s important to not stockpile excessive amounts of OTCs.  Instead, review your current supply to determine where gaps exist in your personal inventory.  Although the DEA’s Prescription Drug Take Back Day scheduled for April 25th has been canceled, many retail pharmacy locations have drop boxes where expired medications can be deposited.
  1. Establish your Healthcare Power of Attorney (HCPA) – A HCPA, sometimes referred to as an Advance Directive, is a legal document that allows another individual to make medical decisions on your behalf when you are incapacitated. The named healthcare power of attorney acts as a healthcare proxy and is called upon to communicate with a patient’s doctor to inform them of the patient’s wishes.  A HCPA can be a family member, friend, or even an attorney.  A lawyer can help you establish an HCPA, or there are many online providers that can execute the required documentation.
  1. Setup your Online Health Record – Many insurance providers and doctor’s offices have online portals available where you can access information on your office visits, medications, vaccine history, diagnoses, lab results, and more. In order to have quick access to this information and avoid needing to call your physician’s office, it is recommended that you set up a username/password and familiarize yourself with the system.  Being able to provide your own information in the event of an illness, can save valuable time for you and your healthcare team.
  1. Review Child Safety Procedures – For those with kids who may now be home from school, the weekend is an excellent time to review safety procedures with your child. Do your kids know what to do in case of an emergency?  Can they provide your address or phone number to a trusted adult?  The weekend also provides ample time to do a walk-around of your home and identify any potential hazards such as missing electrical outlet covers, lack of cabinet locks, lose stair gates, or exposed cords or wires.
  1. Be Active – Go for a walk outside, start seedlings for your spring garden, or stream an online exercise class. Being stuck at home doesn’t mean there aren’t ways to stay fit and be active.  With the current pandemic, a number of companies are offering free subscriptions, so do a little online research, and find something that interests you!

 

Posted March 20, 2020

2020 Spring Newsletter:

Coronavirus Preparation Tips

Key Questions and Answers about Ibuprofen Use for COVID-19

Market Effects from COVID-19

Key Questions and Answers about Ibuprofen Use for COVID-19

If I am experiencing symptoms consistent with coronavirus, should I take ibuprofen?

With the most current information available, the World Health Organization (WHO) has stated they are not recommending against taking Ibuprofen. This means that you can still take ibuprofen to manage symptoms. Please refer to the diagram below for the WHO statement.

 

If I am experiencing symptoms consistent with coronavirus, should I take naproxen or other NSAIDs?

Yes, as long as you follow normal guidelines for daily intake of these medications. There has been no information that naproxen or other NSAIDs have an adverse impact with respect to COVID-19.

 

WHO Ibuprofen Announcement

These questions arose after a March 17th WHO announcement where they recommended against the use of ibuprofen (Motrin, Advil, among other brands) for patients with COVID-19 symptoms, due to a concern that anti-inflammatory drugs could worsen the COVID-19 infection. Likewise, acetaminophen (Tylenol, among other brands) is still safe to use as directed.  The theory hypothesized that ibuprofen could increase an enzyme, ACE2, that is used by the virus to infect the host. There is no evidence that other medications impacting that pathway, such as ACE inhibitors and ARBs, play any role in COVID-19 either.  Patients should continue to use prescribed medications as directed by their physicians.

 

For more information from WHO about COVID-19, visit https://www.who.int/news-room/q-a-detail/q-a-coronaviruses.

 

Posted March 20, 2020

2020 Spring Newsletter:

Coronavirus Preparation Tips

Market Effects from COVID-19

COVID-19 have you Quarantined? – Weekend Activities for your To-Do List

 

Priority Review and Rare Diseases Reign Supreme for 2019

Based on the FDA’s count, there were 48 novel drug approvals in 2019 with 60% receiving FDA fast track status, priority review, or accelerated approval.  This count does not include vaccines, plasma products, or gene therapy products.  When the majority of drugs are being reviewed in an expedited time frame, it is a strong indicator that the market is shifting towards the specialty drug space.  The high number of expedited approvals begs the question, “how much of an advantage is an expedited approved when everyone else is getting the same treatment?”

Many of the newly approved agents are first-in-class and indicated for rare disease states.  Oncology approvals continue to outpace approvals for other disease states, with approximately 20% of drugs approved for the oncology space, whether for diagnosis or treatment.

Three new infectious disease agents were approved in 2019, which is a positive step in developing new therapies to combat antibiotic resistance.  Because of the Generating Antibiotics Incentives Now Act (GAIN Act), three agents (Fetroja, Recarbrio, and Xenleta) received priority review as Qualified Infectious Disease Products (QIDPs).  With the rise of antibiotic resistance, the need for new antibiotic innovation is increasingly important, and the FDA’s Safety and Innovation Act (FDASIA) seeks to promote their development.

What does 2020 hold?  PHSL highlights five top trends to watch out for in this year’s drug approval space:

  1. Digital Drugs – expect to see an increase in the approval of digital therapeutics and digitally enabled drugs, as technology moves into the mainstream pharmacy space.
  2. NASH Drugs – Drugs indicated to treat nonalcoholic steatohepatitis (NASH), or a fatty liver, are expected to be approved in 2020. With a high price tag and potentially huge patient market, payers should monitor these approvals closely.
  3. Gene Therapy – targeted therapies based on patients’ genetic factors promises to be a key area. This high-dollar space may be a cash cow for those targeting disease states with a sizeable patient population.
  4. Biosimilars – Will 2020 be the first year that an “interchangeable” biosimilar is approved? If not, we expect the number of biosimilar approvals to steadily increase, creating a more commodity-like atmosphere in the biologic space in products with multiple biosimilar competitors.
  5. Expedited Reviews and Approvals – As seen in 2019, expect the FDA to continue approving many products via the fast track, breakthrough, priority review, or accelerated approval processes. With the high number of specialty drugs being approved, this may become the new norm of drug approval.

A full listing of 2019 approvals, by approval type, is shown in the chart below.

2019 FDA New Drugs

 

Posted February 2020

Last Call for USP Chapter <800>

On December 1, 2019, changes will go into effect that impact pharmacies, pharmaceutical manufacturers, and wholesalers. The United States Pharmacopeia (USP) introduced its new chapter <800> on handling hazardous drugs. Regulatory agencies worldwide will begin enforcement on December 1, 2019.

The USP initially announced a June 1, 2019 rollout for chapter <800>, but a six-month extension has provided pharmacies, long-term care facilities, and other affected entities increased time to bring their facilities and standard operating procedures up to code.

Several important considerations exist for pharmacies and other entities that handle hazardous drugs:

  • New requirement for externally vented, negative pressure labs for manipulations (other than counting or repackaging) of hazard drugs (HDs)
    • Splitting/crushing (HD) tablets no longer allowed in regular workspace
  • New requirements for designated areas for receipt, unpacking, and storage of HD

For more information on compounding and handling hazardous drugs, full chapters are available for free download at: https://www.usp.org/compounding.

While facilities dedicate significant energy, time, and resources into finalizing compliance, new regulations on hazardous waste (HW) disposal from the Environmental Protection Agency (EPA) have already gone into effect. August 21, 2019 marked the federal effective date of EPA’s Resource Conservation and Recovery Act (RCRA) Part 266 Subpart P policy on hazardous waste pharmaceuticals.

New requirements for HW management under Subpart P may prove costly for both pharmacies that produce over 220 lb. of hazardous waste in one calendar month and for manufacturers that function as reverse distributors.  Key takeaways include:

  • Sewer prohibition: HW pharmaceuticals may not be disposed of down the drains or flushed
  • Requirements for EPA-approved HW transporters for shipment of non-creditable HW pharmaceuticals
    • Non-creditable HW pharmaceuticals —defined as pharmaceuticals that do not have a reasonable expectation to be used/reused or reclaimed—must be shipped using an EPA-approved HW transporter
    • Potentially creditable HW pharmaceuticals—those in original packaging, undispensed, and expired less than one year–have a reasonable expectation to receive manufacturer credit. Potentially creditable products can be shipped from healthcare facilities using common carriers (e.g., UPS, USPS, FedEx)
  • New standards for residues remaining in “empty” containers:
    • “Empty” containers are defined as empty vials, syringes, unit-dose, and stock/dispensing bottles smaller than 1 liter or 10,000 pills
    • Residues of empty containers are not regulated as HW, but containers larger than these sizes are deemed as HW.

PHSI’s view is that manufacturers and distributors of bulk package-sized hazardous drugs, such as warfarin and spironolactone, should take a closer look at the new EPA and USP <800> regulations. Buyers may become more hesitant to purchase large quantities of hazardous pharmaceuticals. Hazardous drugs deemed broken/leaking, repackaged, dispensed, and expired past 1 year automatically become classified as non-creditable HW. An increase in generated hazardous waste each month may result in a healthcare facility becoming required to abide by all sections of Subpart P.  Subpart P went into effect on Aug 21, 2019 in Iowa, Alaska, Indian Country, and some U.S. territories. Remaining states have until July 21, 2021 to adopt the new regulations. Check with your state for specifics.

PHSI would like to thank our student, Carissa Dolan, LECOM Pharm.D. Candidate, for her contributions to this article.

 

Posted November 2019

2019 Fall Newsletter:

2020 Formulary Exclusion Lists

2020 Formulary Exclusion Lists

2020 Formulary Exclusion Lists:

A Review of Express Scripts, CVS Caremark, and OptumRx

It’s that time of year again, PHSI’s annual review of the PBM formulary exclusion list updates!  Express Scripts (ESI), CVS Caremark, and OptumRx have published their formulary exclusion lists for 2020.  Based on PHSI’s calculations, OptumRx leads the way with 246 new formulary exclusions.  Of those 246 exclusions, 169 (69%) were for brands that have covered generic equivalents.  CVS Caremark added 100 new exclusions; 32 of those 100 exclusions (32%) were for brands with available generics.  ESI will exclude an additional 35 drugs, 13 (37%) of which are multisource brands.  The new 2020 exclusions, as researched by PHSI, are as follows:

Chart 1 New Formulary Exclusions

Excluded multisource brands with available generics are as follows:

Chart 2 New Formulary Exclusions - Brands with Generics

During the review, PHSI made the following observations:

  • OptumRx seemed to pay more attention to the topical corticosteroids class this year, excluding an additional 13 agents that may not have specific generic equivalents. Examples of excluded agents include Psorcon cream, Ultravate lotion, and Cloderm cream.
  • With the 2020 additions, OptumRx more than tripled the number of drugs on its list of excluded brand-name medications with generic equivalents. The total number of drugs on OptumRx’s list of excluded brand-name medications with generic equivalents is now approximately double that of ESI’s list.  Optum indicates that “these brand-name medications have been identified as having available generic equivalents covered at Tier 1 on the formulary.”  This change may signal OptumRx’s increased commitment to reduce unnecessary drug spend.
  • ESI seemed to focus on the hematological class for 2020, with approximately 14% of the new exclusions coming from this category. ESI’s list of agents excluded for 2020 includes Jadenu, Jadenu Sprinkle, Nuwiq, Granix, and Mulpleta.  PHSI believes that ESI may be leading the PBM charge as it relates to hematological agent exclusion.  With many new hematological products expected to launch, we anticipate that this will become a more tightly controlled category in subsequent years.
  • CVS focused heavily on the dermatological category for 2020 exclusions, with an additional 19 dermatology agents being added to the exclusion list. Examples of excluded agents include mupirocin cream, Acanya, Finacea Gel, and fluocinonide cream 0.1%.
  • CVS is making a strong push to exclude high cost dietary supplement agents. Twenty-five dietary supplements were added to the exclusion list for 2020, with folic acid being the preferred on-formulary alternative.  Because these products are not FDA-approved and often have high costs, this can be an effective way to manage plan drug spend.  Examples of excluded dietary supplements include Xyzbac, Mebolic, Dexifol, and Vasculera.
  • CVS Caremark is becoming manufacturer-specific in their formulary exclusions; they note five products where specific NDCs are excluded. For example, CVS’s formulary excludes benzonatate NDCs 69336-0126-15 and 69499-0329-15.  Excluded NDC 69336-0126-15 has a per-unit WAC of $71.42, while pharmaceutically equivalent GPI competitors have WAC pricing of $2.20 per unit.  For a product that may be reimbursed at a non-MAC rate, choosing the correct manufacturer’s product can have impactful reimbursement consequences for payers.
  • With the launch of lower cost generic tadalafil, all three major PBMs have chosen to exclude brand Cialis in 2020.
  • As mentioned in our 2019 Exclusion List Review, ESI continues to use indication-based management for the “inflammatory conditions” drug class. Reviewing the updates to that category, Inflectra and Renflexis are no longer preferred agents for 2020.

Each of the major PBMs has taken a different approach to managing drug spend in 2020 and formulary exclusions continue to play a major role.  PBMs exclude products because of clinical, financial, and humanistic reasons.  They are making value judgments and have decided covering these products is no longer warranted.  This article represents PHSI’s analysis of publicly available information regarding the three PBMs’ formulary exclusion lists for 2020.  Readers are encouraged to assess the lists for themselves.  Links to the exclusion list source information are provided below.

 

Posted November 2019

2019 Fall Newsletter:

Last Call for USP Chapter <800>

The Importance of PBM Contract Review Post Implementation

One of the biggest responsibilities of health plans and self-insured employer groups is selecting a PBM partner.  When that selection is being made, health plans and large self-insured employers frequently undertake an RFP (request for proposal) process, narrow down the candidates, and then perform a diligent review of the finalists.  Once a PBM is chosen, the health plan or employer group reviews and negotiates contract terms to finalize an agreement.

Health plans or employer groups enter into PBM contracts that make several guarantees, specifically as it relates to rebates, PBM operational performance (guarantees), and reimbursement rates.  Although a diligent review should be performed before the agreement is signed, what steps are health plans and employer groups taking after the agreement is in place to ensure that the contract terms are being met?  When dealing with PBM contracts, it is imperative that guarantee language is clearly defined.  A regularly scheduled review of the data is critical to ensuring contract obligations and guarantees are being met or exceeded.

When rebates are being calculated, the contract should clearly specify which claims are eligible for rebates.  Will rebates be paid on specialty drugs, and if so, how is a specialty drug defined?  Does the site of dispensing (retail vs. mail) impact the rebate?  How does the contract define a brand vs. generic drug?  Are there different rebate guarantees for 30-day vs. 90-day retail prescriptions? These are only some of the questions that should be answered in the contract language, but having well-defined terms is half the battle.  Once the contract is in place, an ongoing assessment is critical to ensure the plan performance meets the expectations.  For one of our employer group clients, this means a quarterly review of claims data and a comparison of the data against the rebate guarantee information provided by the PBM.  By monitoring the data, we proactively identify any discrepancies, estimate rebate dollars based on historical trends, and better negotiate future PBM contract extensions.  Whether the assessment is performed in-house or outsourced to consultants may depend on the individual health plan or employer group.

When evaluating reimbursement rates and effective rate guarantees, health plans and employer groups need to ensure that brand and generic drug definitions are clear.  The contract language should also include verbiage around different reimbursement scenarios.  Contracts should list what reimbursement rates will apply to single-source generics and prescriptions dispensed with different DAW (dispense as written) codes, such as DAW 5, brand dispensed as a generic.  Using the defined definitions, claims data is used to audit and ensure that the claims are being reimbursed appropriately and rate guarantees are being met or exceeded.  A review of the data can also identify scenarios that are negatively affecting the health plan or employer group, including identifying specific drugs that are having a negative financial effect.  Although some situations may be allowed under the current contract, a review can pinpoint problematic areas for future contract renegotiation discussions.

Negotiating PBM contracts with well-defined terms is crucial.  Concise contract language makes it easier to conduct post-contract audits and ensure that the PBM is meeting or exceeding the contractual terms.  Health plans and employer groups should have programs to monitor rebate guarantees, proactively identify discrepancies, and bring them to their PBM’s attention for resolution.  These reviews also assess other factors and provide insight into the PBM operations, enabling the health plan or employer group to negotiate better terms in future agreements.  PHSI has extensive experience helping health plans and employer groups evaluate PBM contracts and analyze data.  Let us know if we can help!

Posted May 2019

 

2019 Spring Newsletter:

Biologic Naming Update

Biologic Naming Update

The FDA has released “Nonproprietary Naming of Biological Products Guidance for Industry.”  This document includes guidance for both 351(a) products (original biologics) and 351(k) products (biosimilars).  Biosimilar suffixes have four letters and are devoid of meaning.  These suffixes are designed for tracking, adverse event reporting, and to aid in prescribing. Related biological products and biosimilars may have different indications for use, but pharmacists do not typically receive information on a patient’s disease state to know which manufacturers’ product to pick.  The biologic suffixes help by allowing prescribers to issue prescriptions using the correct suffix to cover the exact indication needed for the patient.

Reactions to the FDA’s guidance have been mixed.  Originally, the FDA proposed to apply the suffixes retroactively to existing biologic products.  On March 7, 2019, FDA released additional guidance on naming conventions for biologics.  The full guidance is available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632870.htm.

There are several important considerations for pharmaceutical manufacturers, pharmacies, and payers.

  • Existing biologic products that are currently FDA approved will not be assigned four-character suffixes – this is a reversal of the FDA’s previous guidance on this topic
    • Any new biologic or biosimilar introduced in the future would receive a four-character suffix.
  • New biologic products, including insulins and growth hormones (among others), will receive a four-character suffix.

PHSI’s view is that “nothing” will be sorted before “something”, so products that do not have a suffix may be listed before/above products that do have a suffix.  This means that the non-suffix originator products will likely appear before biosimilars in pharmacy systems and EMRs when showing chemical names, which may lead prescribers and pharmacists to see them before/above the biosimilar products for product selection purposes.

Beyond the chemical name field, there are EHR implications due to the RxNorm[1] listings for biologic products.  Biosimilars do not link to the original brand product in RxNorm and subsequently in electronic transactions that rely on RxCUI.  For example, each of the three available infliximab products (brand and two biosimilars) have different Generic RxCUIs[2] because of the 4 letter suffixes added to the “generic” name of the biosimilars.  So those biosimilar versions of infliximab do not link to the originator brand for product selection purposes.

From the compendia perspective, it will be interesting to see how product selection options are displayed for biologic products in the future.  Wolters Kluwer has announced that they are offering a file to help their customers determine potential substitution groups for biologic products.  Currently, compendia listings for biosimilar products do not directly link those products with the original biologic product of the same molecule.  In other words, originator biologics and biosimilars do not share a GPI or GCN.  Offerings like a substitution grouping file would provide additional insights to pharmacies, payers, prescribers, and EHRs regarding product selection options for biologics.

As biologic and biosimilar products evolve, more discussions will occur around how to properly identify specific biologic product selection options for prescribers.  For more information on the pharmacy, payer, and prescriber implications, contact PHSI.

 

[1] RxNorm, from the National Library of Medicine, “provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software, including those of First Databank, Micromedex, Gold Standard Drug Database, and Multum. By providing links between these vocabularies, RxNorm can mediate messages between systems not using the same software and vocabulary.”  More information available at https://www.nlm.nih.gov/research/umls/rxnorm/.

[2] RxCUI stands for “RxNorm concept unique identifier.”  “Everything in RxNorm receives an RXCUI, which is unique to that concept. An RXCUI is essentially the “name” of a concept that computers read and understand.”  More information available at https://www.nlm.nih.gov/research/umls/rxnorm/overview.html.

Posted May 2019

 

2019 Spring Newsletter:

The Importance of PBM Contract Review Post Implementation

FDA Proposed Framework for Digital Therapeutics: “Prescription Drug-Use-Related Software”

By now you may have seen FDA’s Federal Register Notice,  “Prescription Drug-Use-Related Software”, which establishes a docket seeking public input on digital therapeutics.  The proposed framework is for discussion purposes only; it is not a draft guidance but a way for FDA to seek input from stakeholders.  The document gives insight into how FDA may approach digital therapeutics, specifically the regulation of the software’s output.  The comment period for this proposed framework document closes on January 22, 2019.[1]

PHSI’s blog has previously discussed how countless new digital therapeutic technologies are being developed.  Stakeholders including prescribers, pharmacists, payers, and patients will be impacted by labeling and compendia listings for these products and the myriad of others with drug-use-related software in development.

One of the key components of the FDA’s proposed framework is the following:

“Software that is part of a system comprising a device constituent part or is itself a device constituent part of a prescription drug-led, drug-device combination product, and such software provides a function or information that is essential to one or more intended uses of the drug-led, drug-device combination product.  In that case, if such software meets the device definition, the software would be considered part of the device that is a constituent part of the combination product and would be regulated as such.”

PHSI’s interpretation of the framework is that drug labeling regulations (i.e. the labeling requirements of the Federal Food, Drug, and Cosmetic Act) will apply to the output of the software “disseminated by or on behalf of a drug sponsor for use with one or more of the drug sponsor’s prescription drugs” because it accompanies a specific drug.

Software not accompanying a specific drug would not be regulated as labeling, “unless its categorization changes.”  If a drug sponsor licenses software that was originally disseminated by an outside company and then disseminates that software for use in conjunction with a specific drug, it would not be regulated as labeling.

The two labeling types delineated are as follows:

  • FDA-required labeling
    • Drafted by the manufacturer
    • Reviewed and approved by FDA (part of NDA, ANDA, or BLA) initially and when most changes to the labeling are proposed
    • Includes information that is “essential for a provider to make an informed decision about the risks and benefits of prescribing the drug for a patient and the information needed to safely and effectively use the drug”
  • Promotional labeling
    • “Disseminated by or on behalf of a drug’s manufacturer, packer, or distributor”
    • Not approved by FDA in advance of dissemination – submitted to FDA at time of initial dissemination or publication
    • Can be submitted to a voluntary advisory comment process prior to dissemination if the sponsor chooses*
    • Generally devised for promotion of the product
    • May have other functions in addition to promotion
    • May include printed, audio, or visual matter descriptive of a drug

* The proposed framework specifies that, “for certain prescription drug use-related software output, the Agency will recommend under the proposed framework that a sponsor use the voluntary advisory comment process prior to dissemination.”

While the output of the prescription drug-use related software is the focus of the proposed framework, it notes that the software itself is the “responsibility of the drug sponsor to ensure the reliability” of the software.  FDA points out that the function of the software could impact the output, which is considered promotional labeling.

The compendia companies publish information provided by manufacturers as well as FDA when adding a new product to their databases.  Information gleaned from the FDA-required labeling is an important component of their processes.  Each compendium may approach digital therapeutics differently.  The proposed framework document in the Federal Register specifically mentions Abilify MyCite®.  PHSI expects that other examples may include inhalers, such as the newly approved ProAir Digihaler, and injection devices that contain sensors, modules, and/or apps.  Using Abilify MyCite as an example, one compendium appears to differentiate the listing from products with the same active ingredient by using the dosage form field.  The FDA approved dosage form for the product is “tablet with sensor.”  Another compendium identified the difference in the product name field only while keeping the same dosage form as existing Abilify tablets.  These differences could impact reimbursement of the product at the pharmacy.

Another digital therapeutics example is Sandoz and Pear Therapeutics jointly-developed app called “ReSET-O” that is cleared by the FDA via a 510(k) and is categorized as a Class II device.  “ReSET” was listed in the Elsevier Gold Standard compendium earlier in 2018 and is now listed in the Red Book as deactivated; as of this writing, it has not been listed in Medi-Span’s PriceRx, First Databank/Analysource, or Cerner Multum.

As additional products that combine a drug and prescription drug-use-related software are introduced, the strategies used to identify the products will continue to evolve.  Compendia, manufacturers, and healthcare professionals will want to be familiar with the FDA’s proposed framework and the potential implications for all stakeholders.  Current listings should be reviewed for potential negative impact on digital therapeutics reimbursement to prevent pull through issues during the launch process.  PHSI can assist manufacturers with this review and strategic planning to prevent launch challenges.

Additional Resources

[1] https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments.

 

2019 Winter Newsletter:

The Evolution of Retail Discount Generic Programs