Radar on Market Access

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.

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.”

Radar On Market Access: Study Examines Effects of Strategies in SBS Management

May 23, 2019

People with short bowel syndrome (SBS) need a high-touch approach to be effectively managed. Option Care Enterprises, Inc. has a nutritional support team providing clinical interventions, and it recently released a study showing that this approach can save millions of dollars in costs per year, AIS Health reported.

People with short bowel syndrome (SBS) need a high-touch approach to be effectively managed. Option Care Enterprises, Inc. has a nutritional support team providing clinical interventions, and it recently released a study showing that this approach can save millions of dollars in costs per year, AIS Health reported.

People with SBS have a hard time absorbing nutrients and maintaining hydration and electrolyte balance, and diarrhea is common. Dehydration is a common, even fatal, aspect of this condition, and it often results in hospitalization with an average three-day length of stay.

Patients who are released from the hospital and receiving home parenteral support often are readmitted due to dehydration. Option Care has nutrition support teams that include a registered dietitian, nurse and pharmacist to manage these patients, including assessing whether they are getting the appropriate home parenteral nutrition volume.

Researchers evaluated 116 people with a diagnosis of SBS who were at least 18 years old and started on home parenteral nutrition between June 1, 2017, and June 1, 2018.

Of the 116 patients, 14 were readmitted to the hospital within two weeks of being discharged, but none of those readmissions was due to dehydration. Sixty-three interventions — all of them increases in parenteral nutrition volume — were made during the four weeks following discharge.

Researchers assumed an average three-day hospitalization for each of those 63 adjustments, resulting in an estimated 189 hospital days saved in the first month after discharge. With each hospital day costing $2,000, this translates into $378,000 in health care dollars saved in the first month. Projected annual hospital days saved were 2,268, and projected annual health care dollars saved were more than $4.5 million.

According to Mary Englert, area lead, nutrition support dietitian at Option Care and co-author of the study, “it is important to constantly assess each patient’s estimated fluid needs, especially in the early post-surgical phase of their treatment.”

Beyond the financial savings from avoiding a readmission, patients are not at risk of acquiring a hospital-acquired infection, which itself also can be costly. Their quality of life is better as well, says Englert.

This study, she tells AIS Health, demonstrates that “proactive interventions by nutrition support clinicians resulted in a reduction in unplanned hospital admissions for dehydration, therefore reducing costs that would have otherwise been incurred by less careful monitoring.”

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

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.

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).

All three have the potential to save payers and patients significant money. Charline Shan, R.Ph., vice president, access experience team at payer insights and strategy firm Precision for Value, says plans have multiple options for structuring their formularies with the amount of generic options available.

Generics are typically included, with brand drugs placed on preferred or nonpreferred tiers based on price, “but not all are required or have to be on the formulary since there are many branded and therapeutic equivalent options,” she says.

Most people with COPD are covered by Medicare, and CMS requires that a minimum of two products for each category or class be available on the formulary. However, Medicare Part D plans may also consider additional factors when structuring their formularies for COPD patients, including the total cost of care, and that may lead them to implement more selective branded choices on formularies than commercial plans, Shan says.

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

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.

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.

Researchers found that there has been rapid uptake of the programmed cell death-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors. In 2014, following the FDA approval of Merck & Co., Inc.’s Keytruda (pembrolizumab) in September, there were 2,403 people treated with an immuno- oncology checkpoint inhibitor. That number rose to 212,473 in 2018, with six products on the market boasting numerous indications.

The use of biosimilars — which the institute defines on a broader basis than only those therapies approved through the 351(k) pathway — “in terms of volume is still modest,” said Aitken, with these therapies representing less than 2% of the total biologics market in 2018. But in those areas where a biosimilar is available, “there is reasonably rapid uptake.”

Radar On Market Access: CBO Says Proposed Rebate Rule Will Cost Government $177B

May 14, 2019

When HHS unveiled a proposed rule in late January aimed at eliminating drug rebates in Medicare Part D and Medicaid managed care, the proposal was met with mixed responses. A recently released score from the Congressional Budget Office (CBO) calls into question whether the administration chooses to move forward with the proposal in its current form, AIS Health reported.

When HHS unveiled a proposed rule in late January aimed at eliminating drug rebates in Medicare Part D and Medicaid managed care, the proposal was met with mixed responses. A recently released score from the Congressional Budget Office (CBO) calls into question whether the administration chooses to move forward with the proposal in its current form, AIS Health reported.

The proposal would do away with the safe harbor protection in the anti-kickback statute for rebates negotiated between manufacturers and PBMs starting Jan. 1, 2020.

In the CBO’s report, the agency projects that if the rule is implemented as proposed, it will increase federal spending by approximately $177 billion from 2020 to 2029. Of that total, spending on Medicare Part D premiums would increase by about $170 billion. Without rebates to keep premiums low, beneficiaries would face higher premiums. The agency anticipates that “rather than lowering list prices, manufacturers would offer the negotiated discounts in the form of chargebacks,” which are shared with beneficiaries via a manufacturer payment to a pharmacy.

The report, however, also concludes that “no current system could both meet the proposed rule’s standards and facilitate chargebacks.”

If “rebates could no longer be paid to PBMs in Medicare Part D,” but “systems are not available to support retail pharmacy chargebacks,…this would be an untenable situation,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, making it “reasonable to delay” the proposed implementation date.

“The increase in premiums was expected by many, but the growth in federal spending was somewhat surprising given that lower upfront prices would generally benefit the end payer, which in this case is the federal government,” says Jeremy Schafer, Pharm.D., senior vie president, director, access experience team at Precision for Value. “It seems changing the safe harbor may not accomplish patient savings or reduced government spending as hoped for by the administration.”