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Radar On Market Access: Troy Medicare Aims to Launch Pharmacist-Centered Model in NC

June 25, 2019

Troy Medicare, a small Medicare Advantage plan start-up, aims to shake up the North Carolina MA marketplace during the coming fall open enrollment by offering a pharmacist-centered delivery model that will pay local, independent pharmacists directly for enhanced care management services to seniors.

Troy Medicare, a small Medicare Advantage plan start-up, aims to shake up the North Carolina MA marketplace during the coming fall open enrollment by offering a pharmacist-centered delivery model that will pay local, independent pharmacists directly for enhanced care management services to seniors.

“We will go live on Jan. 1, 2020,” in a five-county, “semi-rural” service area around Charlotte, N.C., Troy CEO Flaviu Simihaian tells AIS Health.

Under its model, Troy is working with Community Pharmacy Enhanced Services Network (CPESN). According to Simihaian, the new MA Prescription Drug (MA-PD) plan will contract with CPESN to provide reimbursement of $30 to $50 per member per month (PMPM), relying on participating pharmacists to document their services to determine reimbursement amounts.

Brian Anderson, a principal with Milliman, Inc., tells AIS Health that reimbursement is a key issue.

“It is an innovative model,” he says. “It’s been in the conversation for about 15 years, but the challenge has always been the reimbursement aspect and verifying the [pharmacist] consultations are occurring, and the pharmacist is actually spending time with the patient.”

“It hasn’t worked through the current NCPDP [National Council for Prescription Drug Plans] transaction processes” for Part D plans, Anderson says. “But if they’re just paying an administrative fee PMPM back to those pharmacists, that would be different than having the administrative fee paid through the claims payment system.”

Then there is the question of whether the benefit of pharmacist consultation is offsetting the potentially deeper prescription-drug discounts and higher rebates that large pharmacy chains or mail order pharmacy are able to give, as compared to small independent pharmacies, he says.

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

June 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.

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.”
Multiple drugs are in phase 3 clinical trials for NASH. A front-runner is Intercept Pharmaceuticals, Inc.’s drug, Ocaliva (obeticholic acid), already on the market to treat another liver condition. But the FDA isn’t expected to approve Intercept’s drug for NASH until the second quarter of 2020, Dieterich notes.

Dieterich says he expects NASH medications will “undoubtedly” be marketed as specialty drugs that will be “strictly controlled” by PBMs and insurance companies. He expects such drugs to become available only to the sickest patients, possibly only after a diagnostic liver biopsy is performed.

From a plan perspective, Yusuf Rashid, R.Ph., vice president of pharmacy and vendor relationship management at Community Health Plan of Washington, says NASH “has similarities to other recent new breakthrough therapies where the outcome we are trying to avoid is costly and potentially fatal but not all patients…will even progress to fibrosis. The reason why NASH is more significant is the sheer number of patients that may qualify for treatment.”

Perspectives on CMS’s Drug Pricing Proposals

June 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.

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.

Leerink analyst Ana Gupte sees industry winners across the board. CMS “did not follow through on its proposal to exclude certain protected drug classes, offering a win for the biopharma industry,” she said in a May 17 note. “Managed Care and PBMs also garnered a win as CMS did not follow through on the proposals to pass through pharmacy pricing concessions in the form of DIR [direct and indirect remuneration] fees to patients through reduced cost sharing.”

Dea Belazi, Pharm.D., president and CEO of AscellaHealth, offers a blunter assessment. “I think the final Part D rule is more rhetoric than anything,” he tells AIS Health.

As for negotiated price, “They’re not ready to do anything on pricing at this point,” Belazi says. “I think CMS, with HHS, opened up a Pandora’s box and realized this is not as easy as it seems and they need more time.”

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

June 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.

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.

If the so-called rebate rule were to be effective Jan. 1, 2020, as HHS proposed, “I think carriers would want to have sufficient time to incorporate those requirements into their contracting for 2020, which obviously would be difficult the later that rule is released,” suggests Brandel.

Meanwhile, CMS on May 16 issued a final rule on MA and Part D drug pricing in which it did not follow through on a proposal to pass through pharmacy pricing concessions in the form of direct and indirect remuneration (DIR) fees to patients through reduced cost sharing. That gave Part D sponsors needed clarity on how pharmacy DIR should be reported in bids, says Brandel.

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

June 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.

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.”

When it comes to payer strategies, “unlike other conditions, where there might be alternatives that warrant prior authorization or step therapy, here I expect there to be limited management and more care coordination,” Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors, tells AIS Health.

“If I were a payer, I would definitely use prior-authorization for this, but given the nature of the therapy, you can’t use step edits — it doesn’t really make sense clinically,” says an industry expert who declines to be identified. “But prior authorization really needs to occur extremely quickly.”

“Plans will likely implement a medical policy to ensure appropriate use and ensure adequate monitoring,” says April M. Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC. “This is a one-time IV infusion; any repeated administration has not been evaluated and will likely not be covered until there is data to support that use.”

One concern among some payers is whether members will attempt to be treated with both Zolgensma and Spinraza (nusinersen), another expensive therapy for SMA. “It’s not clear yet if the combination or the sequence is better care until further studies are completed,” says Newcomer.

Perspectives on Diabetic Drug’s Kidney Benefit

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 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.

But Mesfin Tegenu, R.Ph., president of PerformRx, LLC, doesn’t expect a major impact on treatment. That’s because Invokana joins Jardiance (empagliflozin) and Farxiga (dapagliflozin), among others, in a class of type 2 diabetes medications called SGLT2 inhibitors — and some rival products already provide similar benefits, he says.

In 2018, the American Diabetes Association and European Association for the Study of Diabetes issued a consensus statement that “already recommends Jardiance in diabetic CKD [i.e., chronic kidney disease] patients due to the renal benefit,” Tegenu adds.

In the recently announced results for Invokana’s CREDENCE study, Invokana was found to reduce the risk of dialysis or the need for a kidney transplant, which Tegenu says is “good news for plan payers and patients since in addition cardiovascular benefits were also found.”

“However,” he adds, “[cardiovascular] benefits have been known for at least a year and guidelines already recommend these drugs in [chronic kidney disease] patients.”