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Radar On Market Access: Payers Are Wary as First NASH Drugs May Hit U.S. Market Soon

Posted by Judy Packer Tursman on Jun 18, 2019

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

Perspectives on CMS's Drug Pricing Proposals

Posted by Judy Packer Tursman on Jun 13, 2019

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

Radar On Market Access: Outstanding Part D Proposals Created Uncertainty in 2020 Bid Process

Posted by Lauren Flynn Kelly on Jun 13, 2019

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.
 
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Topics: Industry Trends, Provider, Payer

Radar On Market Access: Payers Will Likely Use Various Tactics to Manage Zolgensma

Posted by Angela Maas on Jun 11, 2019

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

Perspectives on Diabetic Drug’s Kidney Benefit

Posted by Judy Packer Tursman on May 30, 2019

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.
 
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Topics: Product Release, Provider, Payer

Radar On Market Access: Express Scripts Takes on Industry's Digital Transformation

Posted by Judy Packer Tursman on May 30, 2019

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

Radar On Market Access: CMS 'Meaningfully Walks Back' on Key Drug Pricing Proposals

Posted by Judy Packer Tursman on May 28, 2019

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

Radar On Market Access: Generic Advair May Help Reduce COPD Costs

Posted by Jane Anderson on May 21, 2019

A new generic alternative for GlaxoSmithKline's Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

Advair Diskus, a combination long-acting beta-agonist and an inhaled corticosteroid, has been one of the most common drugs used for COPD, a condition largely dominated by brand products. The generic, marketed by Mylan and approved Jan. 30, joins generics for two additional COPD devices: a generic for Ventolin HFA (albuterol) and one for Proair HFA (albuterol).
 
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Topics: Industry Trends, Market Access, Product Release, Provider, Payer

Perspectives on BioScrip/Option Care Deal

Posted by Angela Maas on May 16, 2019

Two of the country's largest independent infusion services providers recently unveiled that they have entered into a merger agreement. After coming together, BioScrip, Inc. and Option Care Enterprises, Inc. would be the No. 2 home/alternate site infusion provider in the United States, AIS Health reported.

Under the terms of the deal, publicly traded BioScrip would issue new shares to Madison Dearborn Partners, LLC and Walgreens Boots Alliance, Inc., which are the Option Care shareholders, giving them 80% of BioScrip's stock, with current BioScrip shareholders holding the remaining 20%. The new company would be publicly traded.
 
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Topics: Specialty, Provider

Radar On Market Access: Use of Biologics, Biosimilars Showed Rapid Uptake in 2018

Posted by Angela Maas on May 16, 2019

Almost 5.8 billion prescriptions were dispensed in the United States in 2018, an increase of 2.7% over the previous year, according to the IQVIA Institute for Human Data Science’s report Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023, AIS Health reported.

Retail and mail pharmacies dispensed 127 million specialty prescriptions last year, an increase of 15 million since 2014. In 2018, for the second year in a row, specialty prescription volume grew more than 5% although the medicines accounted for only 2.2% of prescriptions overall. With an increase in the availability of oral and self-injected specialty therapies, these drugs "are increasingly dispensed through retail pharmacies," said Murray Aitken, executive director of the institute, during a May 6 press call.
 
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Topics: Industry Trends, Data & Analytics, Provider, Payer