'Dangerous Nightmare for Cancer Patients': Step Therapy

Roxanne Nelson, BSN, RN

August 09, 2018

Cancer groups have reacted negatively to an announcement from the Centers for Medicare & Medicaid Services (CMS) about allowing Medicare Advantage plans to use a "step therapy" approach to Part B drugs. The policy is part of an effort to rein in prescription drug costs.

This is a "dangerous nightmare for cancer patients," said the Community Oncology Alliance (COA), which sees it as a step toward the government's dictating what cancer treatments Medicare recipients can or cannot receive.

The American Society of Clinical Oncology (ASCO) also said it "strongly objects" to the plan, which it believes will delay access to appropriate treatments.

Such delays could result in irreversible disease progression — and for cancer patients, this could mean the difference between life and death.

Step therapy generally requires a patient to begin treatment with the most cost-effective drug option and to then move on to the costlier treatments. COA refers to this as a "fail first" policy that forces patients and their clinicians to use cheaper and often older and less effective treatments before they are allowed access to state-of-the-art, newer therapies, which are often more expensive. This would happen despite the recommendations of treating physicians who believe the cheaper treatment will not work, the group warns.

"When treating cancer patients, there are very few situations where you have truly interchangeable therapies like a biosimilar and a brand, or between brand and generic, or even two closely aligned therapeutic alternatives," said Ted Okon, executive director of COA. "They're taking Part B — injectable drugs — and Part D — oral drugs — and giving power to a middleman to make decisions on therapy."

Okon told Medscape Medical News that cancer treatment is becoming increasingly personalized and that not all therapies produce the identical result from patient to patient. "You can have two men who are very similar as far as age, cancer type, and stage, but the same treatment may not work because of different genetic makeup," he said. "This action from CMS is going ten steps backward, and not where personalized cancer treatment is going. This is old-school, one-size-fits-all, cookbook medicine that treats every patient the same way."

Will Be Optional

Medicare Advantage plans are private health insurance plans that provide Medicare benefits to 20 million beneficiaries, or about one third of all people receiving Medicare.

In 2012, the Obama administration issued a memo indicating that step therapy is legally forbidden in Medicare Advantage. CMS has now said that it is rescinding that policy and is issuing new guidance that allows Medicare Advantage plans to use step therapy for Part B drugs beginning January 1, 2019.

According to CMS, this new policy "empowers patients with more choices and takes action to lower drug prices." CMS also claims that it is "providing flexibility through private sector tools to negotiate lower prescription drug prices on behalf of beneficiaries."

Beneficiaries will now have the option of negotiating for Part B drugs "in a way that lowers costs and improves the quality of care." Medicare Advantage plans that also offer a Part D benefit will be able to manage across Part B and Part D, so that patients will be able to receive the best therapy, whether it is physician-administered or self-administered.

The program will begin next year, but it is not mandatory for Advantage plans to opt in. If a plan does decide to offer this approach, CMS stated that the decision must be explicitly communicated to beneficiaries through annual notice of change and evidence of coverage documents. Beneficiaries who do not wish to participate in this type of plan will have the option of choosing a different one.

This new approach, said CMS, "must be coupled with care coordination services" that include "discussing medication options with beneficiaries; providing beneficiaries with education and information about their medications; and implementing adherence strategies for beneficiaries on their medication regimen."

"Really Scary Stuff"

Although CMS has framed their press releases around cost savings and said that this new strategy is going to provide better value, competition, and great savings to patients, Okon pointed out that step therapy requirements are driven by financial interests to save money and not by what is in the best medical interest of patients. "These are public companies for the most part, and their goal at the end of the day is to maximize shareholder revenue and not worry about individual patients being treated correctly," he said. "They are concerned about the bottom line and not patient outcomes."

They are concerned about the bottom line and not patient outcomes. Ted Okon

For cancer patients, this can mean the difference between life and death if they are forced to first try out an inferior but cheaper therapy, he noted. Such restrictions are already occurring through the actions of pharmacy benefit managers (PBMs), the third-party administrators of prescription drug programs for commercial health plans, self-insured employer plans, and Medicare Part D plans.

"PBMs are already restricting access to care, and we are seeing delays and switches in therapy all over the map," he said. "This is really scary stuff."

CMS also said that participating plans will be required to pass more than half of the savings generated to the patients. Okon pointed out that although PBMs are required to share savings with the patient, that can be problematic.

"The middleman has to share the savings with the patient, but they can't let the patient pay less," he said. "The patient still has to put out the money, and they can't give it back, and they can't rebate it. So they say — literally — they are going to give 'gift cards' to patients."

CMS has not specifically outlined how patients will receive these savings, but said in its press release that such savings can occur through lower coinsurance payments and rewards programs, which provide patients with benefits such as gift cards.

In its statement, COA noted that it is "perplexed and concerned by the guidance put forth for sharing savings via gift cards."

Okon was also perplexed that CMS believes that offering cancer patients gift cards is going to make up for denying them proper therapy and making them jump through hoops. "If the middleman gets a large enough discount and decides the patient should get an oral drug rather than an infusion, the patient may end up paying more if they don't have coinsurance, and may be pushed into the donut hole faster," he said. "But they'll get a gift card."

Reverse the Decision

ASCO has also expressed strong opposition to the new CMS plan. In a statement, ASCO President Monica M. Bertagnolli, MD, said the society objects to the plans' employing step therapy across physician-administered and self-administered drugs under Medicare Part B and Part D.

She also echoed COA in emphasizing that there is frequently a lack of interchangeable treatment options in modern cancer care. "The optimal care requires patient access to the most medically appropriate drug at the most opportune time, based on the highest quality evidence," she said. "Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medication before they can access the medication prescribed by their healthcare provider."

Bertagnolli added that ASCO "strongly urges CMS to reverse this decision" and that ASCO will continue to oppose any payers' management policy that restricts patient access to high-quality cancer care.

Industry Opines

The professional organizations were joined by the Pharmaceutical Research and Manufacturers of America (PhRMA) in voicing opposition to this move by CMS.

In a statement given to the Regulatory Affairs Professional Society, the group noted that "PhRMA has serious concerns with the new CMS guidance regarding Medicare Advantage coverage of Part B medicines and the implications for patients suffering from complex conditions. Step therapy will delay many patients' access to medicines they need, interfere with the patient-physician relationship, and increase burdens on physicians to comply with new, more complicated requirements."

On the other side of the coin, at least one organization believes that this is a step in the right direction.

"We applaud the administration's focus on bringing down drug prices and increasing access to biosimilar medications," said the Campaign for Sustainable Rx Pricing in a press statement. "The fundamental cause of this crisis is the price that is set by drug manufacturers and drug manufacturers alone, and we will continue our work with the administration, Congress, and other stakeholders to develop additional policies that address the incentives towards ever-higher list and launch prices."

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