Market Access

Radar On Market Access: More Than 1,000 RM/AT Products Are in Pipeline

August 15, 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.

While Zolgensma’s $2.125 million price for a one-time infusion makes it the costliest drug on the planet, many other newer RM/AT products are certainly not cheap. Though many manufacturers are offering various reimbursement schemes, including rebates if a therapy doesn’t work, other outcomes-based deals and multiyear pay-over-time payment options, experts note that many barriers exist in the execution of these strategies.

“In principle, spreading the cost over a five-year period and putting the cost installments at risk based upon efficacy is a good approach,” says Winston Wong, Pharm.D., president of W-Squared Group, about Zolgensma. “However, the devil is in the details. Do we have the systems in place that have the capability to administer a five-year contract?”

According to Wong, “From the manufacturer perspective, a value-based contract implies that no payment would be made if the patient relapses or passes on. Systems are not in place to have the ability to track the patient once therapy is administered.”

MMIT Reality Check on Ulcerative Colitis (Aug 2019)

August 9, 2019

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

According to our recent payer coverage analysis for ulcerative colitis 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 ulcerative colitis treatments shows that under the pharmacy benefit, about 62% and 58% of the lives under commercial and health exchange formularies are covered with utilization management restrictions, respectively.

Trends: In April 2019, Highmark Inc. said it is targeting autoimmune diseases under a new outcomes-based contract with Takeda Pharmaceuticals U.S.A., Inc. for Entyvio (vedolizumab).

MMIT Reality Check on Merkel Cell Carcinoma (Aug 2019)

August 2, 2019

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

According to our recent payer coverage analysis for Merkel cell carcinoma 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 Merkel cell carcinoma treatments shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2018, the FDA gave accelerated approval to Keytruda (pembrolizumab) for use in adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

MMIT Reality Check on Parkinson’s Disease (Jul 2019)

July 26, 2019

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

According to our recent payer coverage analysis for Parkinson’s disease 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 Parkinson’s disease treatments shows that under the pharmacy benefit, about 45% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: Given the number of generic orals, management of the remaining name-brand oral products is restrictive but less so than in other classes. With many strong orals available, understanding how restrictions translate (or don’t) to brand-name products is critical.

Radar On Market Access: Plans Offer More $0 Copay Drugs to Boost Adherence

July 23, 2019

As various players in the health care industry sharpen their focus on disease prevention, some experts tell AIS Health they’re seeing health plans offering more and more “preventive” drugs at no cost to members.

As various players in the health care industry sharpen their focus on disease prevention, some experts tell AIS Health they’re seeing health plans offering more and more “preventive” drugs at no cost to members.

Dean Health Plan recently said it’s “adding even more preventive drugs to our list of drugs available to [members] for $0.” Additions to the list, which total more than 200, include Advair inhalers (fluticasone propionate and salmeterol) for asthma, the diabetes drug Januvia (sitagliptin), and Alendronate for osteoporosis, says Kevin Engelien, manager of large group product and market research at the Wisconsin-based insurer.

To decide what goes on that list, Dean Health Plan works with its PBM, Navitus Health Solutions, in a “no less than monthly” process of reviewing the utilization and effectiveness of drugs, as well as any changing mandates, Engelien says.

It’s not just smaller regional insurers like Dean Health Plan that are making more drugs available to members at no cost.

“I do think there is a trend in non-grandfathered self-insured clients offering preventive drug lists, and also kind of widening their preventive drug lists,” says Stephen Wolff, a pharmacy consultant in Milliman’s Chicago office.

While Wolff attributes the expansion of those lists to the rise of high-deductible health plans in the employer-sponsored insurance market.

“I think the driving force, to the plans that I consult to, is more in trying to make sure that people with chronic conditions get the treatment necessary,” he says. “So even if you have a deductible, you can get first-dollar coverage on diabetes meds, for example.”

In fact, the Internal Revenue Service recently issued new guidance that expands the list of services and medications that patients in high-deductible health plans can access before meeting their deductible.

MMIT Reality Check on Kidney Cancer (Jul 2019)

July 19, 2019

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

According to our recent payer coverage analysis for kidney cancer 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 kidney cancer treatments shows that under the pharmacy benefit, about 58% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Currently, Sutent leads the renal cell carcinoma market and may have bolstered its standing with 2017’s label expansion to include use in the adjuvant setting.