PBM Executives Questioned on Drug Pricing Practices by Senate Finance Committee

In February, executives from seven drug makers testified on prescription drug prices before the Senate Finance Committee. On Tuesday, April 10th, it was the pharmacy benefit managers' (PBMs) turn to testify and be questioned on their pricing practices. Executives from the five largest PBMs appeared before the Senate Finance Committee.

In the search for solutions to the perceived problem of prescription drug prices the adversarial relationship between stakeholders in the prescription drug supply chain hasn't helped matters. Drug makers and PBMs tend to blame each other for rising prescription drug prices. This was evident in both Senate hearings. It takes two to tango, and it takes even more to produce the tangled web of complicated and sometimes abstruse relationships involved in the pricing of drugs.

In the wake of a proposal by the Department of Health and Human Services to no longer grant rebates safe harbor protections, PBMs have been resistant to full transparency, especially as it pertains to the net prices they pay for drugs and other fees they obtain in exchange for administering prescription drug benefits.

The most probing questions Senators posed concerned rebates. Several executives stated that rebates only figured in about 7% of drugs covered in their Medicare Part D plans. Of course, downplaying the role rebates play begs the question why PBMs insist on keeping them. Their argument suggests that getting rid of rebates will lead to higher premiums. This, in turn, raises the question, if rebates don't matter that much why should eliminating them lead to higher premiums. Ultimately, it’s an empirical question whether abolishing rebates will lead to higher premiums.

Traditionally, PBMs have opposed transparency regarding rebates, spread pricing, and a bevy of negotiated fees. PBMs view this as proprietary information that offers them a competitive advantage. Furthermore, they often attempt to reassure end-users that the secretiveness is to their advantage. It's as if PBMs are telling beneficiaries and other stakeholders: "Trust me, it's opaque and confusing for a reason. We're operating on your behalf." Well, that may be so. But, for markets to operate optimally transparency, and what economists call completeness of information, are prerequisites, for all stakeholders involved in transactions.

It's evident, however, that PBMs have begun to embrace more transparency in the healthcare market. Exhibit A may be spread pricing, where PBMs until now have retained as profit the difference between the amount they reimburse pharmacies for a drug and the amount they charge plan sponsors. This has gone on for quite some time. Senators grilled executives on the practice of spread pricing. It appears that spread pricing may soon be subject to a legislative ban. And, PBM executives at the hearing appeared to acquiesce on this point.

Also, several PBMs have carried out preemptive moves designed to demonstrate they can operate in either a rebate-free world, or one in which 100% of rebates are passed through to plan sponsors. Late last year, for example, CVS Caremark unveiled its "Guaranteed Net Cost PBM Model," under which it offers plan sponsors the option of passing through 100% of rebates. It is then up to plan sponsors - employers and health plans - to decide how much of this they will pass on to consumers.

Moving forward, PBMs will continue to have an important role to play in a more transparent and competitive healthcare system. Several decades ago they came into existence as claims processors and adjudicators, and later took on important roles as formulary managers, prescription drug price negotiators, and specialty pharmacy operators. They also run a myriad of disease management programs.

Original Publication: Joshua Cohen, Forbes

Opioid Follow up: Major Crackdown on Prescription Opioid Crime

The Department of Justice and the Department of Health and Human Services yesterday announced that they have charged 60 people with the illegal prescription and distribution of opioids, alleged crimes involving 32 million pain pills.

  • These include 31 doctors, 7 pharmacists, 8 nurse practitioners and 7 other medical professionals, all in Appalachia, where the opioid crisis has struck hardest.
  • Some were also charged for involvement in health care fraud schemes.

Between the lines: Some of the allegations are wild and illuminate the continuing profitable enterprise of prescription opioids.

  • In Ohio, a doctor and several pharmacists were charged with running a "pill mill" that allegedly dispensed more than 1.75 million pills in only 2 years.
  • A Kentucky dentist was charged with pulling teeth unnecessarily, and a doctor was charged for prescribing opioids to his Facebook friends, who would then come to his house to pick them up.
  • And in Tennessee, a medical professional who called himself the "Rock Doc" allegedly exchanged opioid and benzodiazepine prescriptions for sexual favors. Over 3 years, this man allegedly prescribed 500,000 hydrocodone pills, 300,000 oxycodone pills, 1,500 fentanyl patches, and more than 600,000 benzodiazepine pills.

The bottom line: The opioid epidemic may have evolved into being mostly about illicit opioids like heroin and synthetic fentanyl, but these allegations show that prescription drug abuse is far from a thing of the past.

Original Publication: Axios Vitals


Industry Breakthroughs for Gene Therapy

In the wake of the FDA approval of Luxturna, an AAV-based gene therapy for a specific form of blindness, many companies are seeking approval of their newly developed therapies.

Zolgensma, an AAV-based gene therapy for babies with spinal muscular atrophy, is seeking to break into the US market with FDA approval in 2019.

Fewer than 500 children are born each year in the US with the disease known as SMA, and 60% have the most severe form, which means they will never crawl or walk. Novartis has filed for U.S. Food and Drug Administration approval to sell Zolgensma to treat these patients, with a decision expected at the end of the month. It also appears effective in a milder form of the disease that develops in patients who have backup genes that help produce some of the missing protein. There are about 9,000 to 10,000 Americans living with the condition according to David Lennon, president of the Novartis unit that developed the therapy.

The price point of Zolgensma, has come under criticism from the Institute for Clinical and Economic Review (ICER) in Boston. Although Novartis has not disclosed the intended list price for Zolgensma, the company has noted that the treatment would be clinically valuable at $4 million. ICER contends that $900,000 to $1.5 million would be a more reasonable price point.

See BioPharma Dive’s What to look for after Zolgensma’s launch for further detail, and read this List of Gene Therapy Clinical Trials for a breakdown of therapies on the horizon in 2019.


Anthem: IngenioRx Client Transition Update

On January 30th, Anthem announced the accelerated launch of IngenioRx, their new pharmacy benefits manager (PBM) and that they would begin transitioning clients in the second quarter of 2019. Anthem expects to have all clients transitioned before the end of first quarter 2020. Their goal is to make this as easy as possible for your clients and their members. Most of the changes will be behind the scenes so there is very little that they should have to do. If there is something they need to do, Anthem will let them know.

Anthem has spent more than 15 months planning this transition and, based on the results of their rigorous testing, is confident in their ability to transition your clients and their members with as little disruption as possible. More importantly, they are excited about the additional value they will be able to deliver with this move through things like improved pricing and enhanced member tools.

Learn more
Check out Anthem's Client Guide for general information about the move to IngenioRx, along with answers to frequently asked questions. Anthem will share this guide with clients when they send them a client notification email about when they’re moving to IngenioRx.

Original Publication: Beere&Purves

Here’s What You Should Know About the IngenioRx Client Transition:

What will members who use home delivery need to do?

  • Effective on the date of your move, members will begin to fill home delivery prescriptions through the IngenioRx Home Delivery Pharmacy. If they have active refills at Express Scripts mail-order pharmacy, those prescriptions will be automatically transferred to IngenioRx. Approximately 45 days before your move to IngenioRx, we’ll send a targeted letter to members who use home delivery that walks them through the move.

What will members who use specialty drugs need to do?

  • Effective the date of your move, members who fill specialty medications through Accredo will begin to fill those medications through IngenioRx Specialty Pharmacy. If they have active refills, those prescriptions will be automatically transferred to IngenioRx. Approximately 45 days before your move to IngenioRx, we’ll send a targeted letter to these members walking them through the move. Additionally, every member who fills a specialty drug will be contacted by our specialty care team, via telephone, to introduce them to IngenioRx, check in on their care, and help them with the move to IngenioRx.

Are drug lists changing?

  • No.

Are retail pharmacy networks changing?

  • We are still finalizing a few pharmacy network contracts and, while unlikely, it is possible that a pharmacy may move out of network. Any members who are impacted by such a move will receive a letter along with advice on how to move their prescription to an in-network pharmacy.
  • It is our goal to completely match our current pharmacy networks with the move to IngenioRx, and we expect that fewer than 2% of members will have to change pharmacies.
  • For those members who are impacted, we will send a letter approximately 30 days prior to the move to help them transfer their prescription to an in-network pharmacy.

CVS Trend Report

The most recent CVS Trend Report has been published, detailing the company’s performance and future intentions, as well as the industry trends to follow. Read the study for more insights.


First Treatment for Post-Partum Depression

The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.

Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.

The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.

The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.

The FDA granted this application Priority Review and Breakthrough Therapy designation.

Approval of Zulresso was granted to Sage Therapeutics, Inc.

Original Publication: U.S. Food & Drug Administration

Seasonal allergies: Nip Them in the Bud

Spring means flower buds and blooming trees — and if you're one of the millions of people who have seasonal allergies, it also means sneezing, congestion, a runny nose and other bothersome symptoms. Seasonal allergies — also called hay fever and allergic rhinitis — can make you miserable. But before you settle for plastic flowers and artificial turf, try these simple strategies to keep seasonal allergies under control.

Reduce your exposure to allergy triggers

To reduce your exposure to the things that trigger your allergy signs and symptoms (allergens):

  • Stay indoors on dry, windy days. The best time to go outside is after a good rain, which helps clear pollen from the air.
  • Delegate lawn mowing, weed pulling and other gardening chores that stir up allergens.
  • Remove clothes you've worn outside and shower to rinse pollen from your skin and hair.
  • Don't hang laundry outside — pollen can stick to sheets and towels.
  • Wear a pollen mask if you do outside chores.

Take extra steps when pollen counts are high

Seasonal allergy signs and symptoms can flare up when there's a lot of pollen in the air. These steps can help you reduce your exposure:

  • Check your local TV or radio station, your local newspaper, or the Internet for pollen forecasts and current pollen levels.
  • If high pollen counts are forecasted, start taking allergy medications before your symptoms start.
  • Close doors and windows at night or any other time when pollen counts are high.
  • Avoid outdoor activity in the early morning when pollen counts are highest.

Keep indoor air clean

There's no miracle product that can eliminate all allergens from the air in your home, but these suggestions may help:

  • Use the air conditioning in your house and car.
  • If you have forced air heating or air conditioning in your house, use high-efficiency filters and follow regular maintenance schedules.
  • Keep indoor air dry with a dehumidifier.
  • Use a portable high-efficiency particulate air (HEPA) filter in your bedroom.
  • Clean floors often with a vacuum cleaner that has a HEPA filter.

Try an over-the-counter remedy

Several types of nonprescription medications can help ease allergy symptoms. They include:

  • Oral antihistamines. Antihistamines can help relieve sneezing, itching, a runny nose and watery eyes. Examples of oral antihistamines include loratadine (Claritin, Alavert), cetirizine (Zyrtec Allergy) and fexofenadine (Allegra Allergy).
  • Decongestants. Oral decongestants such as pseudoephedrine (Sudafed, Afrinol, others) can provide temporary relief from nasal stuffiness. Decongestants also come in nasal sprays, such as oxymetazoline (Afrin) and phenylephrine (Neo-Synephrine). Only use nasal decongestants for a few days in a row. Longer-term use of decongestant nasal sprays can actually worsen symptoms (rebound congestion).
  • Nasal spray. Cromolyn sodium nasal spray can ease allergy symptoms and doesn't have serious side effects, though it's most effective when you begin using it before your symptoms start.
  • Combination medications. Some allergy medications combine an antihistamine with a decongestant. Examples include loratadine-pseudoephedrine (Claritin-D) and fexofenadine-pseudoephedrine (Allegra-D).

Rinse your sinuses

Rinsing your nasal passages with saline solution (nasal irrigation) is a quick, inexpensive and effective way to relieve nasal congestion. Rinsing directly flushes out mucus and allergens from your nose.

Look for a squeeze bottle or a neti pot — a small container with a spout designed for nasal rinsing — at your pharmacy or health food store. Use water that's distilled, sterile, previously boiled and cooled, or filtered using a filter with an absolute pore size of 1 micron or smaller to make up the saline irrigation solution. Also be sure to rinse the irrigation device after each use with similarly distilled, sterile, previously boiled and cooled, or filtered water and leave open to air-dry.

Interested in alternative treatments? Consider these

A number of natural remedies have been used to treat hay fever symptoms. Treatments that may help include extracts of the shrub butterbur and spirulina (a type of dried algae). However, the benefits and safety aren't clear.

Some people claim acupuncture can help with seasonal allergy symptoms. There's some evidence that acupuncture works, and there's little evidence of harm.

Talk to your doctor before trying alternative treatments.

When home remedies aren't enough, see your doctor

For many people, avoiding allergens and taking over-the-counter medications is enough to ease symptoms. But if your seasonal allergies are still bothersome, don't give up. A number of other treatments are available.

If you have bad seasonal allergies, your doctor may recommend that you have skin tests or blood tests to find out exactly what allergens trigger your symptoms. Testing can help determine what steps you need to take to avoid your specific triggers and identify which treatments are likely to work best for you.

For some people, allergy shots (allergen immunotherapy) can be a good option. Also known as desensitization, this treatment involves regular injections containing tiny amounts of the substances that cause your allergies. Over time, these injections reduce the immune system reaction that causes symptoms. For some allergies, treatment can be given as tablets under the tongue.

Original Publication: Mayo Clinic