Payer

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.

MMIT Reality Check on Urothelial/Bladder Cancer (Jun 2019)

June 7, 2019

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.

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.

Payer Coverage: A review of market access for urothelial/bladder cancer treatments shows that under the pharmacy benefit, about 24% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2019, the FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Balversa (erdafitinib).

Radar On Market Access: Blues Plans Promote Alternative Treatments to Combat Opioid Epidemic

June 4, 2019

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.

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.

However, DeLeo points out that employer policies don’t cover some of the alternative therapies, which is a disincentive for patients facing chronic pain. “It’s at odds with the concept of keeping people off opioids,” he says. For example, acupuncture is covered under certain evidence-based guidelines, as is Botox for migraines, he says. Physical therapy, occupational therapy and chiropractic care also are covered, albeit with policy-set limits, and injections and non-opioid medications are covered, he says.

Independence Blue Cross covers mainstream therapies, says Ginny Calega, M.D., vice president of medical affairs. She also notes that employer groups have been interested in alternatives to opioids, and Independence has communicated with both members and physicians about these alternatives.

Blue Shield of California has seen an uptick in the use of alternative treatment modalities for chronic pain, including physical therapy and acupuncture, although it’s not clear this is instead of opioids or in addition to opioid prescriptions, says Salina Wong, Pharm.D., director of clinical pharmacy programs.

MMIT Reality Check on Endometriosis (May 2019)

May 31, 2019

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.

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.

Payer Coverage: A review of market access for endometriosis treatments shows that under the pharmacy benefit, around 46% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: ObsEva SA announced in May 2019 that they initiated the Phase III development program of linzagolix, a novel, orally administered gonadotropin-releasing hormone receptor antagonist, to treat women with endometriosis-associated pain.

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.”

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

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.

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.”