Blog

Common Ground on Drug Pricing

The following linked article provides viewpoints from many different stakeholders regarding drug pricing.  One of the good discussion points includes that if a manufacturer brings a product to market, Medicaid will pay for it.  Americans drive innovation but just because something is available, does that mean the expectation is that it is covered by health insurance?  What are your thoughts on the societal issues around drug pricing? Will society continue to pay for drug innovation?

http://www.lifescienceleader.com/doc/finding-the-common-ground-on-drug-pricing-0001?vm_tId=1950291&user=1CA2FDB9-E8B9-4FA2-AEF0-DEFE059DB654&utm_source=et_6231169&utm_medium=email&utm_campaign=LSL_09-08-2016&utm_term=1CA2FDB9-E8B9-4FA2-AEF0-DEFE059DB654&utm_content=Pharma%2c+Payers%2c+And+Patients%3a+Finding+The+Common+Ground+On+Drug+Pricing

Drug Transparency Mandated in Vermont

Vermont became the first state to enforce drug pricing transparency from pharmaceutical companies. The bill took effect on June 2nd and requires manufacturers to be open about what goes into the pricing of their drug. The intent is for manufacturers to be held more accountable for their pricing. An act related to prescription drugs (Act no. 165) requires all factors contributing to a drug’s wholesale acquisition cost (WAC) increase to be disclosed.  Manufacturers must demonstrate what percent each factor is attributing to the change and an explanation of why the change has occurred. The Green Mountain Care Board, an independent group tasked with improving Vermont’s healthcare system, and the Department of Vermont Health Access will work together to compose an annual list of up to 15 high expenditure drugs. In order to qualify for this list, the drug’s WAC must have increased over 50% in the last 5 years or seen an increase of 15% over the last twelve months. If a manufacturer’s drug is selected they must justify this increase or face civil penalties of up to $10,000 per violation. Ultimately, the attorney general will collect the manufacturer’s information and publish a report on the board’s public website. To appease bill opponents, names of the drugs in question and their manufacturer will not be released. The bill also requires Vermont’s Medicaid program to use 340B pricing for reimbursement through qualifying health centers.

Health insurance companies must now provide more detailed information on projected prescription costs through their plans. This will be accomplished through online information such as the drugs covered by the plan, the applicable cost sharing amount, drug tiers, prior authorization and step therapy protocols, which is a standard met by Medicare Part D Plans today. These requirements must be met on or before January 1, 2017.

Lowering healthcare cost is at the forefront of many politicians’ minds. While price justification may be one tool to reign in rising expenditures, many question the practicality of the bill. Critics have highlighted that WAC does not usually represent what is being paid after rebates and has little influence on the price paid by patients. Others say that because of the various determinates of drug price such as research and development; transparency of drug prices is not as simple as it sounds. Much like gas or food products, drug prices are based upon changing variables and can often fluctuate depending on market share or drugs in production. Forcing manufacturers to keep drug costs fixed or down may cause less profitable research areas to lose funding. Alternatively some manufacturers could cease making a product, leading to shortages and potential price increases.

It is still unclear how pharmaceutical manufacturers will respond to Vermont. We doubt this new requirement will have any significant import on the overall cost of prescription drugs. It will take time to see how the bill affects its current healthcare system. States may choose to adopt similar bills if Vermont’s increased oversight of pharmaceutical manufacturers proves valuable. Certainly this will not be the last strategy proposed to slow healthcare spending and rising prescription costs.

View Vermont Act 165 at http://legislature.vermont.gov/assets/Documents/2016/Docs/ACTS/ACT165/ACT165%20As%20Enacted.pdf

DEA Drug Take-Back Day October 2016

The next National Prescription Drug Take-Back Day sponsored by the Drug Enforcement Administration (DEA) is scheduled for Saturday, October 22, 2016 from 10:00 am to 2:00 pm at participating locations. Additional information on disposal sites will be made available by September 22, 2016. Visit the DEA website at http://www.deadiversion.usdoj.gov/drug_disposal/index.html for more information on drug disposal.

The DEA typically sponsors two National Prescription Drug Take-Back Days per year, but you don’t have to wait for one of these events to safely dispose of your prescription drugs. There are many authorized collectors around the country that provide drug take-back services year-round.

Bring your unused, expired, and unwanted medication to a site near you. It is important to dispose of medication properly to reduce the risk of harm from taking an expired medication, accidental exposure, and intentional misuse.

Different medications can be disposed of in different ways. Most medication can be disposed of at registered take-back locations. Some locations may have individual limitations on medication that they can accept, but medications and supplies that should be excluded from this process include:

  • Needles and syringes
  • Diabetic testing supplies
  • IV bags and tubing
  • Biohazard material
  • Controlled substances (police stations may be able to handle the disposal of these medications)

To find a Controlled Substance Public Disposal Location near you, visit https://www.deadiversion.usdoj.gov/pubdispsearch.

Electronic smoking devices to be regulated by the FDA effective August 8, 2016

There are an estimated 5.5 million e-cigarette users in the United States.  First introduced to the US in 2007, e-cigarettes are electronic devices that look like cigarettes but atomize liquid into a vapor rather than burning tobacco.  The liquid comes in a variety of flavors and typically contains nicotine.  Most users believe that e-cigarettes are a safer alternative to tobacco cigarettes; this belief is supported by manufacturer marketing.  The vapors produced by e-cigarettes might very well be safer than tobacco smoke, but the data to support this claim is lacking.

A 2015 analysis of 42 common brands of e-cigarette refill liquids was completed by Varlet et al.  This study found that every product contained some measurable amount of potentially harmful compound.  Most of the refill liquids contain nicotine, diethylene glycol, ethylene glycol, ethanol, formaldehyde, and acrolein.  All compounds were within FDA limits, but the long term effect of chronic exposure to these remains unknown.1

E-cigarettes are not allowed to be marketed for smoking cessation, but that hasn’t stopped people attempting to quit smoking by turning to e-cigarettes for help.  A small number of studies have shown smokers reduce the number of tobacco cigarettes while using e-cigarettes, but these studies are old and have several limitations, including insufficient statistical power, unequal losses of participants to follow up, and the use of now obsolete e-cigarette brands.

More recently, a 2015 study conducted by Primack et al. demonstrated, in a longitudinal cohort study of 694 participants between 16 and 26 who never smoked, that use of e-cigarettes at baseline was associated with eventual use of tobacco cigarettes.2  At the start of the study, 2.3% of participants reported e-cigarette use, by the end of the study 70% of e-cigarette users were smoking tobacco cigarettes, compared with 20% of participants that did not use e-cigarettes at the start of the study.

Drawing from data available from the National Poison Data System, Kamboj et al. conducted a retrospective study earlier this year and found that from January 2012 to April 2015 the number of calls related to e-cigarette exposure in children 6 or younger increased from 14 reports in January 2012 to 223 reports in April 2015.  Further analysis showed children exposed to e-cigarettes had greater risk of hospitalization (5.2 times) and greater risk of severe medical outcomes (2.6 times) than those exposed to tobacco cigarettes.3

Effective August 8, 2016, e-cigarettes will be covered under the FD&C Act, as amended by the Family Smoking Prevention and Tobacco Control Act.  The FDA will regulate e-cigarettes the same as it regulates all other tobacco products.  E-cigarettes will no longer be available to purchase for people under 18 and packaging will be required to display the same health warnings as other tobacco products.4

While e-cigarettes might appear to be a safe, convenient alternative to tobacco cigarettes, and other tobacco products, the data continues to suggest that for the majority of patients they are not safe.  Beyond the known possible hazards of potentially toxic compounds, inconsistent quality control and labeling may create additional health risks.  The use of e-cigarettes for smoking cessation should not be considered unless a patient has failed several other proven, effective methods.  If a patient decides to use e-cigarettes, the risks and benefit should be discussed in detail and it should be communicated that e-cigarettes are not necessarily a safer alternative to tobacco cigarettes.

 

 

  1. Varlet V, Farallinos K, Augsburger M, et al. Toxicity assessment of refill liquids for electronic cigarettes. Int J Environ Res Public Health 2015;12:4796-815.
  2. Primack BA, Soneji S, Stoolmiller M, et al. Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr 2015;169:1018-23.
  3. Kamboj A, Spiller HA, Casavant MJ, et al. Pediatric exposure to e-cigarettes, nicotine, and tobacco products in the United States. Pediatrics Published online ahead of print, May 9, 2016. Doi:10.1542/peds.2016-0041.
  4. Food and Drug Administration, HHS. Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetics Act, as amended by the Family Smoking Prevention and Tobacco Control Acts; Restrictions on the sale and distribution of tobacco products and required warning statements for tobacco products. Final rule.  Fed Regist 2016;18:28973-9106.

EHR/EMR Prescribing

EHR/EMR Prescribing

Frequently Asked Questions (FAQs)

Electronic Health Records (EHR) and Electronic Medical Records (EMR) are digital versions of patient-centered health information.  EHRs are becoming more commonly used by healthcare providers, which has been driven by the financial incentives to utilize EHRs.  PHSI helps clients understand EHRs’ impacts on prescribing.  We have gathered three frequently asked questions about EHRs to help provide some insights.

1. What type of EHR systems exist? Does the software exist in the MD office or is it cloud based?

EHR systems exist in a number of platforms.  Some physicians may purchase their own EHR systems from a vendor for use in their specific office.  Other larger groups, such as integrated delivery networks and/or health systems may select an EHR system to be used for their entire network/system.  Approximately 80% of EHR software providers systems have all relevant information loaded at the physician office with updates either pushed or pulled from the EHR central server. The other 20% of EHR providers use cloud based solutions where the physicians’ offices will need to log-in to access files and updates. There are a handful of EHR providers that offer different versions of their software that will dictate whether the updates are pulled/pushed to the physician office or only updated via the Cloud.

2. How often are EHRs updated?

EHR systems may be updated monthly, which is by far the most common update schedule, or even quarterly, which occurs with a number of significant industry offerings.  Few if any providers update their systems more often than once per month.  For prescribers that must manually sync their systems, update frequency may depend on how frequently they load new data.  Web-based platforms are more likely to be updated more frequently and more reliably.

3. Can prescribers use their EHR system to find drugs by brand name?

Yes – This is the most common way that prescribers search for and prescribe medications.

Let us know what questions you have about EHRs by commenting below or contacting us.  PHSI has more detailed insight about adding prescription products to the EHR or discussing your specific issues or challenges with EHRs.

Drug Manufacturer GSK Partners with SmartQuit Smoking Cessation App

As technology continues to improve, many companies are starting to use new tools to give unique patient support. The SmartQuit App, designed by 2morrow Inc., helps patients learn more about their own smoking habits and begin the process of quitting. SmartQuit is the first smoking cessation App proven effective in a clinical trial.  SmartQuit utilizes an Acceptance and Commitment approach and helps patients create a personal quit plan.  The App delivers an 8-day program that is completed prior to the patient’s quit date and then provides them with up to 6 months of additional support.  Patients will be prompted to provide their stress level, time it takes to smoke a cigarette, triggers, concerns about quitting, number of cigarettes smoked daily, price per pack, as well as other information that helps the App tailor suggestions for the patient.  The App works by allowing patients to identify their urge to smoke without acting on it. This adds a mechanism to hold patients accountable while offering an additional support system.

A lite version is free in the App store.  The full program is paid for by some employers, states, and health plans and is available for iPhone, Android, and Windows operating systems.

Several employers have implemented a system where employees who smoke and use the SmartQuit App can receive free starter packs of Nicoderm CQ patches.  Pharmaceutical manufacturer GlaxoSmithKline (GSK) is providing patches to smokers who have completed 2morrow’s SmartQuit App plan.  Although nicotine replacement therapies are over-the-counter, many insurance plans have programs to help pay for these products through their prescription drug benefit. These programs along with personalized tools like the SmartQuit App give patients more options in smoking cessation resources which increases the likelihood of a successful quit attempt. Mobile technology has become an instrumental part of healthcare. It is not surprising that drug manufacturers like GSK are partnering with App developers to reach patients.

More information on the App can be found at http://www.2morrowinc.com/smartquit/

DEA Drug Take-Back Day April 2016

Update:

The most recent DEA National Prescription Drug Take-Back Day on April 30th was the most successful event in the history of the program. Expectations were far surpassed as a total of 893,498 pounds or 447 tons of prescription medication were recovered across the country. The states with the most amounts of medications surrendered included Texas with roughly 40 tons followed by California, Wisconsin, Illinois, and Massachusetts. Pennsylvania collections were also highly successful with a total weight of 22 tons of disposed drugs. “These results show that more Americans than ever are taking the important step of cleaning out their medicine cabinets and making homes safe from potential prescription drug abuse or theft,” said DEA Acting Administrator Chuck Rosenberg. It is safe to say that the value of these events continues to grow and this record will hopefully be eclipsed in the near future.

 

The National Prescription Drug Take-Back Day sponsored by the Drug Enforcement Administration (DEA) is scheduled for Saturday, April 30, 2016 from 10:00 am to 2:00 pm at participating locations.

Visit the DEA website at http://www.deadiversion.usdoj.gov/drug_disposal/takeback to find a disposal site near you.

Bring your unused, expired, and unwanted medication to a site near you. It is important to dispose of medication properly to reduce the risk of harm from taking an expired medication, accidental exposure, and intentional misuse.

Different medications can be disposed of in different ways. Most medication can be disposed of at registered take-back locations. Some locations may have individual limitations on medication that they can accept, but medications and supplies that should be excluded from this process include:

  • Controlled substances (though police stations may be able to handle the disposal of these medications)
  • Needles and syringes
  • Diabetic testing supplies
  • IV bags and tubing
  • Biohazard material

Diabetic testing supplies and needles can be disposed of at home using an opaque container such as a laundry detergent bottle. Make sure the bottle is sealed tightly and dispose of it in the trash.

Some medications are recommended to be flushed down the toilet for quick disposal due to the increased risk associated with these medications. These medications include opiates and other controlled substances.

If you are unable to make it to a location on National Prescription Drug Take-Back Day, two of the local universities with pharmacy schools will be sponsoring drug take-back programs on different days.

April 21, 2016 from 9:00 am to 3:00 pm
University of Pittsburgh
Nordenberg Hall
103 University Place
Pittsburgh, PA 15213

April 29, 2016 from 10:00 am to 2:00 pm
Duquesne University
Bayer Learning Center
600 Forbes Ave.
Pittsburgh, PA 15282

Update on Contraceptives & Pharmacist Prescriptive Authority

Pharmacists’ services continue to expand as pharmacists are getting involved in prescribing and/or furnishing certain medications, such as hormonal contraceptives, in several states.  Listed below is the latest information on initiatives underway in Oregon and California.

Oregon

Pharmacists in Oregon can now prescribe and dispense hormonal contraceptives, both oral and transdermal.  While the Oregon Board of Pharmacy is expected to establish permanent rules based on public input and will consider adoption of the Permanent Rules at their April 7, 2016 Board meeting, they have established temporary rules to enable pharmacists and pharmacies to prepare for implementation of the law.  For each patient, pharmacists are required to obtain a completed Oregon Self-Screening Risk Assessment Questionnaire and to follow the Oregon Standard Procedures Algorithm to perform the patient assessment before prescribing a contraceptive.  If the pharmacist determines that it is not clinically appropriate to prescribe the contraceptive, he or she is required to refer the patient to a healthcare practitioner.  Patients under 18 can only receive a pharmacist prescribed contraceptive if the patient has evidence of a prior prescription from a primary care practitioner or women’s health care practitioner for an oral contraceptive or contraceptive patch.  Additional Board approved training is required for pharmacists who want to participate in prescribing contraceptives.  It is a five credit hour course available online for $250, available at https://pace.oregonstate.edu/catalog/comprehensive-contraceptive-education-and-training-prescribing-pharmacist.

Oregon law requires insurance coverage for prescription contraceptives.  Only religious employers are exempt from the requirement.  A new law extends that requirement to “apply to hormonal contraceptive patches and self-administered oral hormonal contraceptives prescribed by a pharmacist.”  Individual insurers may still have formulary limitations on the specific brands of contraceptives that are covered.  PHSI has heard that Oregon Medicaid is already providing coverage, but it’s unclear if commercial payers have begun providing this specific coverage in the middle of a benefit year.

California

A similar law in California is expected to be enacted on April 1, 2016.  The law permits pharmacists to furnish contraceptives (which can include contraceptives that are administered vaginally and by depot injection), and to “order and interpret tests to monitor drug safety.”  California’s law only permits furnishing by pharmacists who the Board of Pharmacy recognizes as advanced practice pharmacists (APP), which can be gained in as little as a one hour Continuing Education program.  Accredited California schools of pharmacy may also offer an “equivalent curriculum-based training program completed on or after the year 2014” which would also count as sufficient training to participate.

Missing from the discussion has been reimbursement for the pharmacist’s services.  California’s law specifically calls out that, for furnishing emergency contraception drug therapy (ECDT) the “pharmacist, pharmacist’s employer, or pharmacist’s agent may charge a patient an administrative fee of up to $10 above the retail cost of the drug but may not charge a patient a separate consultation fee for ECDT services.”

Colorado, Hawaii, and Washington state legislatures have introduced bills that would allow pharmacists to effectively prescribe contraceptives.

Future Opportunities

PHSI envisions state-by-state growth similar to the now nationwide availability of pharmacist administered immunizations and the growing number of states allowing pharmacists to provide emergency contraception to patients under certain requirements.  Certain states have begun to allow pharmacists to dispense naloxone to patients and/or caregivers without a doctor’s prescription.  As we’ve seen with other clinical initiatives, some pharmacies will evaluate the most effective (profitable) use of their time – be it dispensing other prescriptions or initiating prescriptions for products such as contraceptives.  As pharmacy practice continues to evolve, PHSI envisions a future where pharmacists are compensated for the clinical services they are providing to patients.

Pharmacist prescriptive authority for contraceptives was recently discussed in the PHSI Winter 2016 Newsletter.  The updates above were initiated by feedback from you.  For your reference, the initial article can be found here.

Innovation in 2015

2015 was a banner year for novel drugs approved. There were 45 novel drugs approved as new molecular entities (NME) under New Drug Applications (NDAs) or Biologics License Applications (BLAs) in 2015, up from 41 novel drugs approved in 2014. As a comparison, the FDA has averaged 28 novel drug approvals per year in the 2006 to 2014 timeframe.

Pharmacists and healthcare providers should be aware of new drugs that may be seen in practice. While many of these new approvals are for specialty drugs or orphan drugs with a small patient population that may not be seen in a pharmacy, it is still advisable to recognize and review new products. Questions may arise from patients or caregivers regarding these new products, their administration, dosage, side effects or drug interactions.

The FDA’s Center for Drug Evaluation and Research (CDER) publishes an annual summary of novel drugs, which is an excellent source for newly approved novel drugs. Oncology products led the way with nine newly approved novel drugs. Twenty-nine of the 45 drug products were approved in the US before receiving approval in any other country. Sixteen of the novel drugs approved in 2015 were deemed “first in class”, often with a new mechanism of action, an indication of innovation in the US drug market. Twenty-one novel drugs approved in 2015 were approved to treat rare or “orphan” diseases that impact fewer than 200,000 patients in the US.

The FDA CDER report cited above also focuses on the high level of innovation in 2015 drug approvals. Twenty-seven of the 45 novel drugs approved in 2015 fell into one or more expedited categories, demonstrating that pharmaceutical manufacturers and the FDA are working to bring valuable life-saving medications to market.

This was demonstrated by the following approval categories:

  • 24 Priority Reviews due to the potential for a significant advance in medical care. As a result, these drugs are targeted for a six-month review instead of the standard 10-month review goal.
  • 14 Fast Track Approvals indicate drugs with the potential to address unmet medical needs.
  • 10 Breakthrough Therapies indicate that the drugs’ preliminary clinical evidence demonstrated substantial improvement in at least one clinically-significant endpoint over other available therapies. Breakthrough status is designed to help shorten the development time of a potential new drug therapy.
  • 6 Accelerated Approvals, which allow early approval of a drug for a serious or life-threatening illness and offer a benefit over current treatments. Once accelerated approval is granted, the drug undergoes additional testing to confirm that benefit. This process expedites availability of the drug to patients in need.

As novel drug approvals become more innovative and provide breakthrough care, expect the value of drugs in relation to other healthcare expenditures to rise even more. How do you keep up to date on new and novel drug approvals?

To view the FDA’s CDER Novel Drugs Summary report, visit http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM481709.pdf.

Drug Manufacturers on Social Media

These days, you can find just about everyone on at least one form of social media. Whether it’s Twitter, LinkedIn, or even YouTube, we all want to stay connected and up-to-date with others. The same holds true for drug manufacturers. PHSI researched how drug manufacturers use social media to communicate with patients, healthcare professionals, and employees. Here’s a brief breakdown of manufacturer presence on different social media platforms:

Facebook

  • Drug manufacturers mainly promote disease state awareness, events, and information about their company with links back to their websites.
  • There is no mention of specific drug products on any of the researched manufacturers’ pages.
  • Occasionally, specific OTC drugs can be found with their own Facebook page.

Twitter

  • Manufacturers’ content on Twitter is similar to Facebook. The 140-character restriction results in less information in each post and more links to website resources.

Instagram

  • Some manufacturers are using Instagram, which allows users to post pictures or videos and include a description.
  • Manufacturers mainly use Instagram to promote their company, showcase events attended, highlight patient stories, and provide disease state awareness.

YouTube

  • Many manufacturers have YouTube channels. They include videos which promote their company, provide education and raise awareness of diseases, and highlight patient stories.
  • Most of the manufacturers that PHSI researched did not sponsor or include product training videos.
  • EpiPen was found to have its own YouTube channel to provide training videos.

LinkedIn

  • Some manufacturers use the same information on LinkedIn as they do on Facebook, while others use it strictly for employment purposes.
  • Because LinkedIn is mainly used by business people to connect with colleagues, businesses would be less likely to use this as a way to connect with customers.

Pinterest

  • Manufacturers don’t appear to be on Pinterest.

 

FDA Social Media Guidance

The FDA released three draft guidance documents in 2014 for manufacturers using social media.

  1. Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Draft Guidance)
    a. Companies must submit interactive promotional media to FDA as required by postmarketing submission requirements.
    b. Manufacturers must submit all sites for which it is responsible using the appropriate FDA forms.
    c. Updated listings must be submitted monthly.
    d. Screenshots are required to be submitted initially, but may not be necessary in monthly submissions, depending on the type of site.
  2. Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Draft Guidance)
    a. Communications must be balanced, accurate and non-misleading.
    b. Benefit and risk information should be presented equally, regardless of space.
    c. Risk information should include the most serious risks associated with the product. A hyperlink should also be provided to allow more direct access to risk information and/or FDA approved labeling.
  3. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (Draft Guidance)
    a. Companies can correct misinformation posted by independent third parties, but they are not required to by the FDA.
    b. Manufacturers will need to create internal policies on which information to correct, how it is corrected, and how to document the process.

Refer to the following websites to read the complete FDA draft guidance:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm403810.htm
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM404562.pdf

Although there is an opportunity to use social media outlets for advertising, manufacturers are hesitant to use social media for this purpose. The FDA has already issued warning letters to some firms that they are inappropriately using social media. Once the FDA releases final guidance, manufacturers may be more likely to use social media as a way to reach patients and providers.