Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Dieterich says the entry of first-ever NASH medications will "definitely" offer significant benefit to patients. "There's no question [the drugs will help] — in combination with diet and exercise," says Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System. "It will have to be the whole package."

Topics: Specialty, Industry Trends, Market Access, Product Release, Provider, Payer

According to our recent payer coverage analysis for ankylosing spondylitis 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.

Topics: Specialty, Market Access, Payer, Branding & Marketing

When CMS issued the final rule on Medicare Advantage and Part D drug pricing on May 16, the agency touted its policy changes as ensuring consumers get greater transparency into the cost of Part D prescription drugs and enabling MA plans to negotiate better prices for physician-administered medicines in Part C. Yet, after receiving 4,000-plus comments related to pharmacy price concessions on negotiated price, CMS held back, saying it won't implement this policy for 2020 — or follow through on proposed exceptions to Part D protected drug classes, AIS Health reported.

Among numerous provisions, CMS's final rule implements the statutory prohibition against gag clauses in pharmacy contracts, barring Part D plans from penalizing pharmacies that disclose a lower cash price to enrollees. But the agency decided against implementing a policy redefining negotiated price as the lowest possible, baseline payment to pharmacies.

 

Topics: Industry Trends, Data & Analytics, Provider, Payer

Medicare Advantage and Part D plan sponsors submitting bids for the 2020 plan year faced a considerable amount of uncertainty compared with recent years. On the Part D side, there was "not only one but two pending regulations — both of which would have had a significant impact on bids — and it was difficult for carriers to know 1) how they should bid and 2) how others might be bidding," Shelly Brandel, a principal and consulting actuary in the Milwaukee office of Milliman, tells AIS Health.

Perhaps creating the most uncertainty was when HHS would finalize a January proposed rule that would eliminate safe-harbor protections for rebates paid by manufacturers to plan sponsors under Medicare Part D and Medicaid. CMS in Part D bidding guidance posted May 20 confirmed what it had hinted at in an April memo on how bids should be prepared: the rule would not be finalized before the June 3 bid deadline.

 

Topics: Industry Trends, Provider, Payer

With the first therapy north of $1 million gaining FDA approval last month, payers likely will implement a variety of strategies to manage Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene therapy from AveXis, Inc., a Novartis company. For now, many uncertainties exist with respect to the new treatment and what its place will be in spinal muscular atrophy (SMA) care, AIS Health reported.

According to Lee Newcomer, M.D., principal at Lee N. Newcomer Consulting LLC, payers likely will implement "strict enforcement of the label restrictions, advisory panels to develop clinical criteria for therapy [and] highly specific provider networks to ensure that the therapies are given correctly."

 

Topics: Specialty, Industry Trends, Market Access, Product Release, Provider, Payer

According to our recent payer coverage analysis for urothelial/bladder 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.

Topics: Specialty, Market Access, Payer, Branding & Marketing

Blues plans are promoting alternatives to opioids — and are seeing some increased uptake of alternatives such as acupuncture — but are hampered by employer policies that either don’t cover or place limits on many of those alternatives. Still, employers are showing interest in providing alternatives to opioids, plans say, and individual Blues plans are taking steps to update their coverage and encourage physicians to prescribe non-opioid chronic pain treatments, AIS Health reported.

Caesar DeLeo, M.D., executive medical director at Highmark Health, tells AIS Health that Highmark promotes Centers for Disease Control and Prevention guidelines for chronic pain management, which stress non-opioid treatments.

 

Topics: Industry Trends, Payer

According to our recent payer coverage analysis for endometriosis 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.

Topics: Specialty, Market Access, Payer, Branding & Marketing

The potential use of Invokana (canagliflozin) for chronic kidney disease as well as type 2 diabetes, its current indicated use, recently attracted national headlines. If Janssen Pharmaceuticals, Inc.'s supplemental indication for its medication is approved by the FDA, "it would be the first new treatment for diabetic kidney disease in decades," the National Kidney Foundation said.

The kidney foundation points out that diabetes is a key risk factor for chronic kidney disease. The group says it anticipates strong uptake of Invokana by clinicians and payers facing "high costs and management challenges" in treating advanced kidney disease in people with type 2 diabetes, AIS Health reported.

 

Topics: Product Release, Provider, Payer

Cigna Corp.'s Express Script PBM expects to introduce the industry's first stand-alone "digital health formulary" in 2020, the company said May 16. It intends to use a uniform review process to ensure the safety and quality of apps and devices on the market for diabetes, cardiovascular and pulmonary conditions and behavioral health, AIS Health reported.

By creating a digital formulary, Express Scripts "is using old hat methods to manage these new digital health solutions much like they do on brand and generic drugs or other therapies via utilization management," says Nathan Ray, senior principal in business consulting firm West Monroe Partners’ health care and life sciences practice.

 

Topics: Industry Trends, Data & Analytics, Provider, Payer