Product Release

Radar On Market Access: Despite Approval of New Parkinson’s Drugs, Plans Still Prefer Generics

October 3, 2019

Although three new drugs for Parkinson’s disease have been approved over the last year, plans generally are sticking with the drugs they’ve included on formularies for several years, most of which are generic, experts tell AIS Health.

Although three new drugs for Parkinson’s disease have been approved over the last year, plans generally are sticking with the drugs they’ve included on formularies for several years, most of which are generic, experts tell AIS Health.

That may change in the long term as new gene therapies that currently are in development are approved and come online. But none of those potential new treatments are close to market right now, says Mesfin Tegenu, R.Ph., president of PerformRx.

“Many commonly used therapies for Parkinson’s disease — carbidopa-levodopa, MAO-Bs, dopamine agonists — have available generics, which on most plans would be considered formulary options, or one generic product within each class would be selected as formulary,” Tegenu tells AIS Health.

The FDA in August approved Kyowa Kirin, Inc.’s Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing motor fluctuations. In February, the FDA approved Osmotica Pharmaceutical US LLC’s Osmolex ER (amantadine) for the treatment of Parkinson’s disease. And in late December, the FDA approved Accorda Therapeutics’ Inbrija (levodopa inhalation powder) for intermittent treatment of off episodes in people with Parkinson’s disease taking carbidopa/levodopa.

Still, plans are stocking their formularies with less expensive generic medications. Parkinson’s disease treatment generally progresses through drugs that have a moderate effect but fewer side effects to drugs that are more effective, but have more significant side effects, Tegenu says.

“Choice of which pharmacotherapy to use initially is individualized based on the characteristics of the patient, the disease and the drugs,” he says. “There is no single preferred therapy, and trade-offs are common.”

Plans aren’t expected to cover Inbrija, Tegenu says. “Members would be able to request an exception through the prior authorization process for these products,” he adds. For Osmolex ER, plans generally require failure on trials of immediate-release amantadine.

Radar On Market Access: Health Plans Are Hesitant to Add New Narcolepsy Drugs to Formularies

September 24, 2019

Two newly approved narcolepsy medications offer novel, possibly more effective options to people for whom older medications aren’t working well, but most health plans are requiring patients and providers to try generic alternatives first, AIS Health reported.

Two newly approved narcolepsy medications offer novel, possibly more effective options to people for whom older medications aren’t working well, but most health plans are requiring patients and providers to try generic alternatives first, AIS Health reported.

The FDA approved Jazz Pharmaceuticals’ Sunosi (solriamfetol) for adults with narcolepsy or obstructive sleep apnea in March and Harmony Biosciences, LLC’s Wakix (pitolisant) in August. Sunosi was launched in July, and Wakix is expected to be launched later this year.

Some researchers say Sunosi and Wakix may have advantages over older treatments. Still, plans have been reluctant so far to add Sunosi to their preferred drug lists, and they seem likely to take the same cautious approach with Wakix.

First-line treatment for narcolepsy generally involves stimulant medications such as methylphenidate, amphetamines or modafinil/armodafinil, says Mesfin Tegenu, R.Ph., president of PerformRx. “Efficacy of the agents rarely exceeds around 70% to 80% of the normal ability to stay awake,” Tegenu tells AIS Health.

Some stimulants, including modafinil and some forms of methylphenidates and amphetamines, are available in generic form, Tegenu says. “Many plans may require trial(s) of an available generic product prior to payment of a brand-only formulation, or trial of less costly alternatives to higher-priced generic items if there’s a significant price difference,” he says.

It’s not clear whether either Sunosi or Wakix provide substantially better outcomes than the therapies currently in use, says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC.

Tegenu says that both Sunosi and Wakix are non-formulary products for now for PerformRx, since it’s not possible to know whether they’re equally or more effective than older treatments. They will be “handled the same as all newly available drugs: considered non-formulary until enough clinical data is made available to add them to the covered medications class of drugs.”

Radar On Market Access: New Solutions to Finance High-Cost Treatments May Raise New Questions

September 17, 2019

With concerns mounting about how health plan sponsors will pay for breakthrough treatments with ultra-high price tags, some major insurers are offering up new solutions aimed at easing that burden, AIS Health reported.

With concerns mounting about how health plan sponsors will pay for breakthrough treatments with ultra-high price tags, some major insurers are offering up new solutions aimed at easing that burden, AIS Health reported.

Cigna Corp. “appears at the forefront” of initiatives to cope with super-high-cost drugs, as Citi analyst Ralph Giacobbe puts it, given that the firm recently introduced a new solution that would help clients pay for and manage two gene therapies: Luxturna and Zolgensma.

Members whose plan sponsors pay a per-member per-month fee for Cigna’s new solution — called Embarc Benefit Protection — will pay nothing out of pocket for Zolgensma or Luxturna if they meet the clinical qualifications to be treated with one of those therapies.

“Employers are looking for solutions like that from their health plan partners and the PBMs,” says Steve Wojcik, vice president of public policy for the National Business Group on Health. However, while offerings like Cigna’s could help employers “smooth out the spikes in expenses,” businesses remain concerned about the overall costs of breakthrough therapies in the pipeline, he notes.

Besides Cigna, other major names in the insurance sector, such as CVS Health Corp.’s Aetna and Anthem, Inc., are working on their own solutions to help cope with high-cost therapies, including annuity-style payment arrangements and value-based contracts.

David Dross, managed pharmacy practice leader at the consulting firm Mercer, says some large, self-insured employers that are concerned about ultra-costly treatments are rethinking their decision to forgo stop-loss coverage.

However, issues can arise if clinical and financial management of a high-cost drug are done separately, he adds. In other words, a plan sponsor may determine that a member qualifies for a high-cost drug, but the stop-loss carrier that’s taking on the financial responsibility may not agree.

Trends That Matter for RM/AT Products

September 12, 2019

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

While only a handful of therapies in the broader regenerative medicine/advanced therapy (RM/AT) space are available globally, a new report shows that is likely to change, as there are more than 1,000 products in the pipeline, AIS Health reported.

The Alliance for Regenerative Medicine published the report, titled Quarterly Global Regenerative Medicine Sector Report: Q2 2019, on Aug. 1. It shows there are 1,069 clinical trials using specific RM/AT technologies, which include gene therapy, gene-modified cell therapy, cell therapy and tissue engineering. Ninety-four of those products are in Phase III trials.

Trends That Matter for Medicare Part D Costs

August 15, 2019

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

The study found that, assuming a 61% discount between brand-name and generic drugs, Part D beneficiaries with prescriptions costing between $22,000 and $80,000 per year would have lower out-of-pocket spending if they use brand-name drugs over a generic, AIS Health reported.

The graphics below show the annual out-of-pocket savings associated with generic drugs and the median-point-of-sale price differences of brand-name drugs and their generic counterparts.

Trends That Matter for CMS’s Oncology Care Model

August 1, 2019

CMS’s Oncology Care Model (OCM) is about halfway through its five-year pilot. Developed by the CMS Center for Medicare & Medicaid Innovation, the voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost.

CMS’s Oncology Care Model (OCM) is about halfway through its five-year pilot. Developed by the CMS Center for Medicare & Medicaid Innovation, the voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost.

One criticism of the model is that providers’ costs are compared with targeted costs that are based partly on their spending from 2012 to 2015, the OCM baseline period. When the actual costs come in below the targeted costs, that earns providers a performance-based payment. But with so many costly oncology therapies launching after the baseline period, this is making it hard for providers to gain a performance-based payment, AIS Health reported.

That was the focus of a poster presentation by Tennessee Oncology at last month’s American Society of Clinical Oncology meeting. Researchers maintained that “when avoidable inpatient, post-acute, and emergency department (ED) costs are minimized, a practice’s actual costs should be lower than target costs, allowing practices the opportunity for shared and performance-based savings. However, we hypothesized that the ability for an oncology practice to successfully meet target costs may be hampered by the skyrocketing prices of novel therapy drugs implemented into clinical practice after baseline period cost calculations.”

They examined Tennessee Oncology patients with non-small cell lung cancer (NSCLC) and bladder cancer treated during the second performance period (January through June 2017). Among researchers’ findings:

The researchers concluded that the use of expensive novel therapies in concordance with NCCN guidelines in indications approved after the OCM baseline period “poses significant challenges to practices. Future value-based care initiatives in oncology need more accurate ways to account for rising drug costs and expanding treatment indications to prevent penalties for following guideline appropriate care.”