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Update: Mandating Price Reporting in Prescription Drug Advertisements

In May 2019, PHSI published a blog discussing the Department of Health and Human Services (HHS) agreement to move forward with one of the initiatives of the Trump Administration’s “American Patients First” blueprint. Part of the “American Patients First” initiative  would require drug manufacturers to report list prices on prescription drug advertisements, in hopes that this would result in lower drug prices and reduced out-of-pocket costs for patients.

In June, drug manufacturers Merck, Eli Lilly, and Amgen sued the government to block this regulation. The companies argued that the rule violated their First Amendment rights.  They noted that listing the price of drugs in advertisements could confuse consumers, because the list price is often not what patients pay after insurance coverage.

In early July, a U.S. District Court Judge ruled in favor of the drug companies, stating that HHS had overstepped its authority.  According to Congress, the HHS has no regulatory power to make drug manufacturers report the cost of drugs in advertisements. What comes next is uncertain, but it is expected that the Trump Administration and HHS will evaluate options to make this information available to patients.   It may take a new law to require manufacturers to post these prices.  However, some manufacturers have produced advertisements with this information. We will update you as new information becomes available.

Link to original blog: http://phsirx.com/blog/mandating-price-reporting-in-prescription-drug-advertisements

 

Posted: August 2019

Medicaid Rebates and the Impact of Authorized Generics

Excluding Authorized Generics from Brand Drug AMP Calculations

The Office of Inspector General (OIG) published a review in April 2019 assessing how excluding authorized generics from average manufacturer price (AMP) calculations would impact Medicaid drug rebates. This review was prompted by a 2017 HHS Budget Brief, which stated that excluding authorized generics could save Medicaid about $20 million per year. Through this review, the OIG found that actual savings were about 30 times this prediction.

Under the Affordable Care Act (ACA), the sales of an authorized generic drug from the brand manufacturer to a secondary manufacturer (i.e., the generic labeler or distributor) were explicitly allowed in AMP calculation only after the implementation of the statutory definition of “wholesaler.” Under the rule, the sale of AGs to secondary manufacturers should be included in AMP, if the secondary manufacturer is “acting as a wholesaler for drugs distributed to retail community pharmacies.”    This had a huge impact on Medicaid drug rebate amounts because the resulting smaller AMP reduced the rebates paid to Medicaid.

The OIG reviewed nine brand name drugs that included authorized generic drugs to secondary manufacturers in their AMP calculations. The manufacturers of these nine brand name drugs transferred the authorized generic to a secondary manufacturer and included the transfer price of the authorized generic in the AMP calculation of the brand name drug.  After the manufacturers provided AMP data for each drug, OIG verified the data, removed the authorized generic transactions, and then recalculated the AMP.  The OIG analysis concluded that if Medicaid had calculated AMP excluding authorized generics to secondary manufacturers, Medicaid would have received 46% more in rebates for these nine brand name drugs, amounting to $595 million for the calendar year 2017.

The OIG recommends that the CMS seek legislative change to exclude authorized generic drug transactions to secondary manufacturers from the AMP calculation of the brand name drug, as this was shown to increase manufacturer Medicaid rebate obligations.  CMS agreed with the OIG recommendation; the President’s Fiscal Year 2020 Budget includes a legislative proposal to clarify authorized generic drug sales under the Medicaid Drug Rebate Program.

To read the full OIG review, visit https://oig.hhs.gov/oas/reports/region6/61804002.pdf.

 

Posted June 2019

Cannabidiol (CBD) Oil in Pharmacy

At the end of March 2019, CVS and Walgreens announced that they will start selling over the counter topical products containing CBD in specific states only, due to the legalization of CBD in those states. Cannabidiol, better known by the abbreviation CBD, is one of the most talked about ingredients today. CBD is a non-psychoactive compound or cannabinoid found in the cannabis plant. THC, the psychoactive cannabinoid, is also found in the cannabis plant and responsible for the “high” associated with marijuana. Since CBD is non-psychoactive, it will not give the euphoric “high” that THC exhibits.

CBD can be extracted from marijuana or hemp. Under the 2018 Farm Bill, hemp is defined as a THC less than 0.3% and is considered legal by the federal government. However, some states include CBD under the definition of marijuana. In these states, CBD may be illegal or considered medical marijuana, limiting its distribution and sales. There is only one FDA approved CBD containing product, Epidiolex, for the treatment of seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome who are at least 2 years old. While Epidiolex is the only agent FDA approved, there are many CBD containing products in the marketplace. There are a wide variety of proposed uses for CBD oil including anxiety, arthritis, cancer pain, acne, Alzheimer’s, and smoking cessation. Trials for nearly 100 different indications are currently taking place.

An overwhelming amount of companies are producing CBD containing products, so knowing how to select a quality product is essential in the market today. Some factors to consider include extraction technique, where the hemp was grown, third-party testing with published lab results, and price. Companies that provide products grown in the USA, extracted by carbon dioxide, and include published testing results should be better quality products. Popular forms of CBD oil include oral capsules, tinctures for sublingual use, lotions, ointments, and vape pens. If ingesting CBD, some common side effects include dry mouth, diarrhea, vomiting, decreased appetite, weight loss, somnolence, drowsiness, fatigue, and elevated liver enzymes. There are drug-drug interactions and drug- herbal interactions if taking CBD oil orally.  Knowing about the product and its possible interactions is important for safe use. Patients should talk to a health care professional if considering using CBD products to determine safety.

Of note: The FDA is sending warning letters to companies that claim any of their CBD products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. While there are proposed benefits, CBD only has the legally approved use for the treatment of seizures in Lennox-Gastaut syndrome or Dravet syndrome.  FDA does not support CBD as a dietary supplement.

Below depicts a map of medical marijuana use by state:

state-laws-map-norml-org

Source: https://norml.org/states

 

Posted: June 2019

Three Prescribing and Dispensing Steps Impacted by the Drug Compendia

The electronic drug record is becoming more important with each drug approval and launch.  Most drug records remain static because the prominent attributes of a drug product (active ingredient, dosage form, route of administration, and strength) do not change.

The static nature of the drug listing can lead to unwanted consequences for a drug product.  These are the 3 areas that are most impacted by the drug compendia listing.

  1. Prescribing – Electronic prescribing continues to grow. To create a new electronic prescription, prescribers need to perform an “alpha” search for the intended product utilizing the drug compendia data in the EMR/EHR system.  Issues arise when the prescriber needs to differentiate between multiple dosage forms or delivery devices for a product.  Challenges can occur when a system limits the number of characters displayed and does not permit an accurate depiction of the product, which is needed for proper selection.  Consequently, prescriptions are not being written for the intended drug due to difficulty selecting the product electronically.
  1. Product selection at the pharmacy – The prescription is written for a brand and the pharmacy system prompts the pharmacy staff to use a generic product option for dispensing. This is generally business as usual in retail pharmacies but may not be appropriate in the case of a brand that is a line extension placed in the same classification (GPI or GCN) as the original brand.  In this case, the generics available may only be substitutable, or A-rated, to the original brand.  The issue is that the generics are not bioequivalent or therapeutically equivalent to the brand line extension, and the pharmacy system did not take that into account when it displayed the substitution options.  Consequently, prescriptions are lost due to the lack of a unique classification for the brand line extension.
  1. Product dispensing and reimbursement – The product is packaged as a 2-pack, which is intended to be the entire prescribed therapy. Issues occur when the technician and pharmacist mistakenly believe only one should be dispensed and the package is broken instead of dispensing it as a unit.  The pharmacy would be overpaid for the product if the PBM reimburses the pharmacy at the package price.  The patient would require a refill but be told it is too soon for the insurance to cover it and could be forced to pay cash.  If the remaining 1-pack is not dispensed again, it could expire and be returned to the manufacturer.  The consequences include pharmacy partners experiencing payment, inventory, patient therapy and outcomes issues, and increased returns processing.

 

Each of these issues can be avoided.  Through forecasting the drug compendia listings and identifying potential challenges before they happen; actions can be taken to avoid or mitigate challenges.

Contact PHSI today to discuss your drug compendia concerns and challenges.  PHSI will review the drug and collaborate on communications with the drug compendia to document the proposed vision.  The optimal time to consider this review is prior to product approval and launch.

PHSI offers many services regarding the drug compendiaContact PHSI with your drug compendia questions!

 

Posted: May 2019

Mandating Price Reporting in Prescription Drug Advertisements

In May 2018, the Trump Administration released a blueprint titled “American Patients First”, detailing their plan to lower drug prices and reduce out-of-pocket costs for patients. While there are many approaches under evaluation, one strategy was to incentivize manufacturers to lower list prices by mandating list price reporting on prescription drug advertisements.  On May 8th, 2019, the Department of Health and Human Services agreed to move forward with requiring manufacturers to show the list price on drug advertisements. This requirement applies to prescription drugs covered by Medicare or Medicaid and that are priced at $35 or more for a course of treatment or 1-month supply. The rule will soon appear in the Federal Register and take effect 60 days after publication.

Manufacturers have begun to adapt to these new changes prior to the new rule taking effect. In February, Johnson & Johnson became the first company to provide pricing for their blood thinner, Xarelto®. Xarelto® commercials now give the drug’s list price plus typical patient out-of-pocket costs. The information appears on screen at the end of the commercial and includes a website where people can enter their insurance information to get more specific cost information. Consumers are able to see that without insurance, Xarelto® costs $450-$540/month.

It is doubtful whether mandating drug prices on advertisements will reduce drug prices; however, patients and providers will have access to costs that were previously difficult to obtain.

To read the full story, visit: https://www.hhs.gov/about/news/2019/05/08/hhs-finalizes-rule-requiring-manufacturers-disclose-drug-prices-in-tv-ads.html

To read J&Js actions, visit: https://www.cnbc.com/2019/02/07/johnson-and-johnson-will-start-listing-drug-prices-in-tv-commercials-.html

In June 2018, PHSI asked our followers about the impact of advertised list prices.  Find the results here: http://phsirx.com/survey-results/june-2018-question-of-the-month

What impacts do you expect from the inclusion of list prices in drug advertisements?  Will the cost information reduce the number of patients discussing these medications with their health care providers?

 

Posted May 2019

 

Read more at the update post: Update: Mandating Price Reporting in Prescription Drug Advertisements

World Health Organization 2019-2020 Influenza Vaccine Recommendations

Every February, the World Health Organization (WHO) releases their recommended compositions for the influenza virus vaccines for the coming influenza season. These recommendations consist of four strains of influenza to be included in egg-based vaccines.

On February 21, the WHO released their recommendations for the 2019-2020 influenza season for 3 of the 4 strains, which included:

  • An A/Brisbane/02/2018 (H1N1)pdm09-like virus
  • A B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)
  • A B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage)

The WHO delayed their recommendation for the final influenza A component for the 2019-2020 influenza season due to the high mutation rates seen in the H3N2 strain. After an additional month of observation, the WHO released their final recommendation to vaccinate against an A/Kansas/14/2017 (H3N2)-like virus.

Egg-based vaccine production is the slowest vaccine production method, due to the many complicated and time-consuming steps involved in the process, and remains the most common production method for influenza vaccines. The WHO aims to release their recommendations as early as possible, while still accounting for accuracy and allowing enough time for vaccine production to take place. Delaying their full recommendations is extremely unusual.

PHSI predicts that the WHO’s month-long delay in releasing the recommendations will likely have an impact on influenza vaccine supply and may lead to more vaccine shortages. PHSI also believes that this delay may lead to an increased demand for cell-based flu vaccines in the upcoming and in future influenza seasons. This will be an interesting story to follow as the 2019-2020 influenza season approaches.

 

Posted: May 2019

FDA Pushes for Over-the-Counter Naloxone

In early 2019, the FDA announced that they would be supporting efforts to move naloxone from a prescription drug to an over-the-counter product. In an effort to speed up the process, the FDA developed and tested naloxone Drug Facts labels (DFL) required for OTC products.  The Drug Facts label is the panel published on all OTC products and contains information on active ingredient, purpose, uses, warnings, and directions for taking the product.  The FDA has never preemptively developed and tested an OTC DFL, which is a testament to their commitment to provide better naloxone access. There are two DFLs available from the FDA, one for naloxone nasal spray and another for a naloxone auto-injector. There is no denying that naloxone is a valuable tool to prevent opioid overdose deaths, but there may be additional barriers that limit uptake of OTC naloxone.

Cost

While the cost of saving a life is immeasurable, those who do not know they or their loved ones are at risk for an opioid overdose may not see the value in obtaining naloxone. Manufacturers and the FDA should work to ensure that access to OTC naloxone is not cost prohibitive.

Access

The ease of access to naloxone may also factor into a patient’s interest in obtaining the product. If they are required to purchase it behind the counter and present an ID, that may scare off some from purchasing naloxone.  If/when naloxone can be purchased in the front-end of a store, access could increase for patients/caregivers.  The price point of the OTC product may influence access even in the front end as this could prove to be a highly pilfered item.

Stigma

While no one knows who patients are buying the naloxone for, there is still a stigma surrounding naloxone as a medication to save drug addicts. The general public may not be aware of the potential for accidental overdose of legal opioids and the benefits of naloxone. There are also people who believe that naloxone shouldn’t be so widely distributed when other lifesaving medications (i.e., epinephrine injections and insulin) are restricted and have a high out-of-pocket cost.

Education

Pharmacists should be sure patients using opioid medications and their caregivers are aware of the risks of opioid overdoses and the potential for naloxone to reverse the effects. Family members and friends of someone with a drug problem should also be educated on the availability and uses of naloxone as a lifesaving medication. Pharmacists and healthcare providers should use each opportunity to educate patients, caregivers, and the general public about the benefits of purchasing naloxone in case of emergency.

All states currently allow for naloxone to be obtained at the pharmacy without previously obtaining a prescription. OTC naloxone will expand access to the product and ideally get it in the correct hands to prevent overdose deaths.

You can learn more details by reading the FDA’s statement on efforts to develop over-the-counter naloxone at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-naloxone

 

Posted: April 2019

Safe Needle Disposal Resource

Safeneedledisposal.org provides comprehensive resources for consumers to learn how to safely dispose of used medical sharps (i.e. needles, lancets, auto-injector, infusion sets, etc.). The website provides guidance and regulations on safe needle disposal for each state in the US. An interactive map allows the user to click on their state and review the disposal instructions.  A list of all the places where sharps can be safely disposed is included by state or by zip code search. The location name, address, contact phone number, service area, and if the site provides sharps containers is listed for each location. The information is also available to print.

This website provides a resource center for patients or providers with several quick-reference guides and educational materials about safe disposal of sharps. Resources for businesses include state agency contacts so that businesses and healthcare facilities can learn more about the laws in each state and obtain referrals for medical waste disposal companies in the area. Federal resources listed on this website include links to The Bloodborne Pathogen Standard and the Hazardous Materials Regulation laws in the United States.

The website also lists drug specific programs for safe disposal.

The website provides a very nice overview of where to dispose of sharps products as well as several excellent resources for consumers and providers.  Pharmacists can benefit by incorporating the resources into patient awareness and education efforts.  How will you incorporate the safety resources into your processes?

 

Posted: April 2019

Allied Against Opioid Abuse Toolkit

Allied Against Opioid Abuse (AAOA) collaborated with the National Community Pharmacists Association (NCPA) and individual state pharmacy associations to develop a collection of resources specific to community pharmacy and their patients. AAOA is a national organization dedicated to increasing education and awareness to prevent abuse and misuse of prescription opioids.

These materials are designed to help pharmacists engage and educate patients and prescribers about safe use, storage, and disposal of prescription opioids. The toolkit can help pharmacists raise awareness among patients and caregivers through patient handouts, engagement guides, tips for talking with patients and caregivers, social graphics, and safe storage and disposal training.

Independent pharmacies in Connecticut, Florida, Minnesota, Ohio, Pennsylvania, and Tennessee who contributed to the development of these resources will receive this toolkit in the mail. Pharmacists in other states can access the materials online here.

The toolkit materials are presented in a very easy-to-read format and would be helpful for patients and caregivers with opioid prescriptions. The AAOA Toolkit serves as a great starting point for pharmacies.  PHSI would like to see information on communicating with patients and caregivers about naloxone availability for appropriate patients.

Educating patients on the rights, risks, and responsibilities associated with prescription opioids is key to solving the opioid crisis.

Poison Prevention Week 2019

The third week of March was declared National Poison Prevention Week by President John F. Kennedy in 1962. In 2019, National Poison Prevention Week is March 17th – March 23rd. Save the Poison Help number (1-800-222-1222) in your cell phone so you’ll have it in case of an emergency.

The best way to prevent poisonings is to identify harmful substances and safely store or remove them from your home. Poisonings can occur through a variety of forms, including:

  • Medications (prescription, over-the-counter, vitamins, and supplements)
  • Art supplies
  • Snow salt
  • Pesticides
  • Alcohol (for children)
  • Household cleaners
  • Carbon monoxide
  • Liquids such as windshield wiper fluid, gasoline, paint thinner, and baby oil
  • Snake and spider bites

Thoroughly search your kitchen, bathroom, bedroom (cosmetics, nail polish, perfume, cologne), laundry room, garage, basement, and storage areas for potentially unsafe items.

While poisonings are most common among children under 6, people of all ages should be aware of the risks of poisons in the home and at work. Poisonings can occur by ingestion or inhalation, or through contact with the eyes or skin. If contact with a harmful substance is suspected, you should immediately call the Poison Help Line at 1-800-222-1222, even if there are no signs of a poisoning. You will be connected to your local poison center, one of 55 national poison control centers in the United States. Expect to be asked questions about the exposed person, the potential poison, the method of contact, and timing of the exposure.

You can safely dispose of medications during the upcoming National Prescription Drug Take-Back Day. Learn more at https://takebackday.dea.gov/.