Market Access

Radar On Market Access: New Postpartum Depression Drug Presents Payer Challenges

April 2, 2019

The FDA’s recent approval of the first medication specifically aimed at treating postpartum depression is drawing a favorable response from clinicians, while payers could face challenges.

The FDA’s recent approval of the first medication specifically aimed at treating postpartum depression is drawing a favorable response from clinicians, while payers could face challenges.

PBM executives tell AIS Health that the postpartum depression drug, Zulresso (brexanolone) injection, is likely to be covered under the medical, not the pharmacy, side of the benefit.

Zulresso’s initial U.S. list price “will be $7,450 per vial, resulting in a projected average course of therapy cost of $34,000 per patient before discounts,” says Alexis Smith, a spokesperson for Zulresso’s manufacturer, Sage Therapeutics, Inc.

As the medication must be administered as a 60-hour continuous intravenous infusion, it’s a challenge for a new mother to be hospitalized in an approved facility for two-and-a-half days for an IV infusion, says Dea Belazi, Pharm.D., president and CEO of AscellaHealth. Moreover, he says, there is “the fact that there are possible extensive side effects and the data on its [Zulresso’s] effectiveness [are] moderately better than placebo. The cost will also play a barrier,” he adds.

Camille Hoffman, M.D., associate professor in the University of Colorado’s Department of Ob/Gyn, describes the newly approved drug as “a breakthrough medication” that “rapidly improves postpartum depression out to, at least, 30 days following the one-time treatment.”

She acknowledges that the need to administer Zulresso via a 60-hour IV drip and its restricted distribution might present challenges. However, she says, “I hope that payers will consider these potential barriers in light of how quickly it acts to help women with severe postpartum depression.”

MMIT Reality Check on Opioid Dependence (Mar 2019)

March 29, 2019

According to our recent payer coverage analysis for opioid dependence treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for opioid dependence treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for opioid dependence treatments shows that under the pharmacy benefit, more than 42% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: To combat the opioid crisis, CMS in June 2018 guidance included an Information Bulletin providing states with considerations when designing approaches to covering critical treatment services for Medicaid-eligible infants with Neonatal Abstinence Syndrome, a post-natal opioid withdrawal syndrome that causes lengthy and costly hospital stays. Via AIS Health.

Trends That Matter for Cystic Fibrosis Medications

March 28, 2019

Payers typically use tools such as prior authorization and utilization review to manage cystic fibrosis treatments, but PBM experts say they are on the cusp of implementing more innovative strategies that might help to improve adherence while addressing the cost of cystic fibrosis drugs, AIS Health reported.

Payers typically use tools such as prior authorization and utilization review to manage cystic fibrosis treatments, but PBM experts say they are on the cusp of implementing more innovative strategies that might help to improve adherence while addressing the cost of cystic fibrosis drugs, AIS Health reported.

Cystic fibrosis, an inherited chronic disease that attacks the lungs and digestive organs, is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. CFTR modulators and other therapies carry a high price tag, typically costing $250,000 to $368,000 per year. Other drugs, most of which do not have generic equivalents, can add tens of thousands of dollars to that total.

The majority of payers use traditional strategies, including pipeline monitoring, pharmacy and therapeutics committee drug review for formulary positioning, and prior authorization to confirm both the diagnosis and the presence of the specific genetic mutation targeted by the cystic fibrosis drugs, says Lynn Nishida, vice president of clinical product at Boston-based WithMe Health.

Still, “a growing number of payers are looking for out-of-the-box solutions for additional strategies in managing these drugs,” Nishida says. Cystic fibrosis drugs typically receive orphan drug status, which means payers cover them because they’re the only option for patients, but it can also mean they’re associated with higher costs, she says.

Managing infections in cystic fibrosis patients is a priority, says Mesfin Tegenu, R.Ph., president of PerformRx. However, effective antibiotics are also a main driver of cost.

Adherence to cystic fibrosis medications can be a challenge to manage, with studies showing a total reported mean adherence rate of 48% and a large drop-off in adherence in the adolescent years.

 

MMIT Reality Check on COPD (Mar 2019)

March 22, 2019

According to our recent payer coverage analysis for COPD treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for COPD treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for COPD treatments shows that under the pharmacy benefit, more than half of the lives under all three formularies are covered without utilization management restrictions.

Trends: Highmark Inc. said in April 2018 that it is working with AstraZeneca under an agreement for Symbicort, a medication used to improve lung function in patients with asthma and chronic obstructive pulmonary disease. Via AIS Health.

Perspectives on Novel Drug Management in 2019

March 21, 2019

With the FDA approving multiple novel new therapies over the past couple of years, we should expect to see more of the same moving forward. But that innovation is not cheap, and the pharmaceutical industry likely will continue to offer products at higher price points than ever before, AIS Health reported.

With the FDA approving multiple novel new therapies over the past couple of years, we should expect to see more of the same moving forward. But that innovation is not cheap, and the pharmaceutical industry likely will continue to offer products at higher price points than ever before, AIS Health reported.

As payers struggle to rein in high specialty drug prices, many have turned to copay accumulator programs, and this trend shows no signs of slowing. “There was an increased focus on copay accumulator programs in 2018,” comments Amy Nash, Pharm.D., president of RelianceRx, the specialty pharmacy affiliate of Independent Health. She tells AIS Health she expects to see “further refinement of copay accumulator programs from payers and additional strategies from pharma to prevent them.”

Moving forward, Nash tells AIS Health, “specialty drug price increases will likely continue to be less frequent and at a lower percentage increase than previous years. We will likely see newly approved products priced lower than competitors to drive utilization.”

The industry could see “a handful of novel gene therapies with curative intent,” says Mesfin Tegenu, president of PerformRx. However, as the prices of these drugs and other innovative treatments continue to grow, “The high prices will necessitate a paradigm shift in the way medicines are paid for….Unsustainable price increases [are] forcing new payment models and novel cost controls.”

According to Jeremy Schafer, Pharm.D., senior vice president, director, payer access solutions at Precision for Value, “Gene therapies may experience the biggest paradigm shift we will see in the near future.”

In the oncology space, the FDA last year approved the second tissue-agnostic drug: Loxo Oncology, Inc. and Bayer Corp.’s Vitrakvi (larotrectinib).

In 2019, Tegenu tells AIS Health, “We may see many new agents with new mechanisms of action, particularly site-agnostic chemotherapeutic agents….Cancer continues to be the most targeted therapeutic area of focus in terms of drug development.”

MMIT Reality Check on Glaucoma (Mar 2019)

March 15, 2019

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for glaucoma treatments shows that under the pharmacy benefit, more than 58% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: Prime Therapeutics LLC’s 2019 National NetResults Formulary excludes Rhopressa (netarsudil solution), a new mechanism of action for glaucoma. Via AIS Health.