Insurance

Insurance Expertise for Free

It’s that time of the year again… Open Enrollment, when you can change your health insurance policy or plan. But you can’t change unless you know what your needs are, and can calculate what your budget is and what expenses will be. Insurance is frustrating, it’s daunting, and with a bleeding disorder, it’s expensive.

But I just saw this on Facebook, which made me happy for two reasons: 1) a licensed insurance broker can help you get started for free, and 2) he’s a wonderful person I’ve known for a long time.

Meet Alexander Ell!

For over 10 years, Alex has helped over one thousand clients with their insurance across multiple states and numerous insurance companies. Alex’s goal is to walk you through the process, providing non-biased advice about the best plan for your needs and goals. His website helps you learn the basics of insurance, defines the many acronyms that insurance loves to use, and has a Frequently Asked Questions section.

On Facebook, he wrote: “Hey everyone! If you hear of any friends or family that need help with their Medicare or Health Insurance, please send them my way. I’ve been a licensed insurance broker for over 10 years. My services are free and I provide non-biased advice about the best plan for their needs and goals. I’m licensed in ID, NV, OR, WA, TX, GA, and FL. If you have any questions, please reach out to me. https://capitalrealm.com

Alex has navigated the complex healthcare system for himself as he has hemophilia. Now he’s here to do the same for you! Contact him to get started with a free consultation today.

Co-Pay Caveats

The Texas Bleeding Disorders Coalition announced recently with pride that HB 999 passed unanimously, 31-0, out of the Senate. This bill will eliminate copay accumulator adjuster programs on state health plans in Texas. Patients with many chronic conditions and no generic options will no longer be penalized by CAAPS and have access to their life saving medication. This is the result of the hard work of so many over the last two legislative sessions.

What are accumulators, and why are they so important to those with bleeding disorders? Read the second of a two-part article by Paul Clement to learn why.

Insurance Company Efforts to Thwart Patient Assistance Programs Part 2

By Paul Clement

Copay Maximizeris also known as variable copay program.  Maximizer programs are a recent development in insurance, and are similar to Accumulator Adjuster Plans (AAP) in that they do not count the manufacturer’s copay assistance payments toward the patient’s deductible or out-of-pocket (OOP) maximum. They differ in that the maximum value of the manufacturer’s card is divided by twelve and applied evenly throughout the benefit year and there are no OOP costs for factor. Plan members are not hit with a “copay surprise” (see last week’s blog) with a maximizer program, but they are still on the hook for paying their annual deductible and coinsurance on all other drugs and services until they reach their OOP maximum for the year. And like AAPs, copay maximizer programs often use deceptive language in descriptions of the program, as insurance companies deliberately attempt to mislead plan members by claiming they are a benefit.

To implement an AAP or copay maximizer, the health plan requires a member to enroll in a separate AAP or copay maximizer program. The plan then deems certain specialty drugs, such as factor, to be “non-essential health benefits.” Non-essential drugs are still covered by the plan, but they are not subject to the Affordable Care Act (ACA) Essential Health Benefit requirements and can be removed from the OOP maximums required by the ACA, which in turn, enables the health plan to completely deplete all of the patient assistance funds!

Depleting all of the plan member’s assistance funds puts the sustainability of the patient assistance programs at risk. Although maximizer programs avoid the AAP copay surprise, they negate the intended benefit of patient assistance programs—and remove a safety net for patients who need expensive drugs like factor but cannot afford them.

What if you, a plan member, do not want to sign up for an AAP or maximizer program? Many plans make their AAP or maximizer program a “benefit” you can’t refuse. If you do not enroll, you are subject to a higher coinsurance, sometimes as much as 50%, and because the plan has deemed factor a non-essential health benefit, the coinsurance, along with your deductible, does not count towards the annual OOP maximum. This would potentially expose you to OOP costs exceeding $100,000 or more a year—not signing up is obviously not an option if you need factor. And even though this tactic would result in you paying many times more than the permissible annual OOP limits under the ACA, insurance companies are claiming the practice is legal. Their position is sure to be tested in the courts in coming years.

Both AAPs and maximizers reduce the health plan’s cost by shifting drug costs to manufacturers and plan members. High costs for drugs often lead to poorer health outcomes as a result of members avoiding use of the specialty drug—and this increases the risk of complications (like joint damage for people with hemophilia), potentially resulting in higher costs to the health care system.

And there’s one more threat to co-pay assistance.

Alternative Funding Companies (AFCs) are also known as patient advocacy programs or specialty carve-out programs. These companies include some pharmacy benefit managers (PBMs) and several third-party vendors which offer their services to health plan sponsors, such as employers that fund their own health coverage, promising to lower their drug costs. If an employer signs on, the AFC eliminates or “carves out” specialty drugs, like factor, from the health plan’s formulary and deems them “non-essential health benefits” to bypass ACA laws and regulations, including limits on OOP costs. Usually, the health plan member does not know this has happened until they place an order for their specialty drug and received a denial for the prescription or are charged a high coinsurance because the drug is now “non-essential.”

      At this point, the AFC steps in and offers to “rescue” the plan member (from a problem the AFC itself created)—you‚— by providing them the specialty drug at little or no cost. They then collect detailed personal information from you and, using a database of copay assistance programs, enroll you in multiple assistance programs, both pharmaceutical and private patient assistance programs (which is not insurance), to help cover the cost of the drug. AFC vendors also usually require you to sign a patient authorization form certifying that you are not enrolled in a health care program that pays for any portion of your prescription drug costs, in order to qualify you for some types of patient assistance (a certification which is usually patently false). When the funding runs out or if you are denied assistance, the drug is then usually covered by the plan using a “formulary exception process.” This means you must petition the insurer to cover the drug once again. And like maximizers, the “offer” to enroll with the vendor is not one you can refuse: those that do refuse are hit with exorbitant coinsurance rates they cannot afford.

Alternative funding companies are widely viewed by patient advocacy organizations as unethical because they deplete funds that have been allocated for people who truly need them. They flout the intent of patient assistance programs, which were created to help patients who genuinely cannot afford the cost of care—not to save money for plan sponsors. In addition, the process of removing drugs from the formulary, denying prescriptions, collecting personal data, enrolling patients in assistance programs, arranging for delivery of specialty drugs and then, later, returning them to the plan, all involve delays in which patients cannot access their therapy—delays which can pose a threat to patient health and even their life. These companies also impact the sustainability of vital patient assistance programs, with some companies responding by reducing the amount of assistance they provide or eliminating their patient assistance programs altogether.

Like AAPs and maximizers, alternative funding vendors are not transparent: they use duplicitous, deceptive language, describing their programs as a “benefit” and “advocacy services”—and they deceive both employers sponsoring health plans as well as plan members. (Many employers do not realize what they are signing up for.)

If you suspect you are being asked to sign up for one of these programs, contact your local hemophilia organization, or the NHF or HFA for assistance. And if you have a commercial health insurance plan and are experiencing a disruption in services or exorbitant coinsurance, including your factor being labeled as “non-essential,” contact your employer and let them know what is happening and how it is affecting your life—they may not realize how their health plan choices affect you.

The Copay Surprise

The Texas Bleeding Disorders Coalition recently announced—with pride— that HB 999 passed unanimously, 31-0, in their Senate. This bill will eliminate copay accumulator adjuster programs on state health plans in Texas. Patients with many chronic conditions and no generic options will no longer be penalized by CAAPS and will have access to their life saving medication. This is the result of the hard work of so many over the last two legislative sessions.

What are accumulators, and why are they so important to those with bleeding disorders? Read a two-part article by Paul Clement to learn more.

Insurance Company Efforts to Thwart
Patient Assistance Programs

By Paul Clement

Hemophilia therapies—both factor and emicizumab—are extraordinarily expensive, potentially costing several hundred thousand dollars per year. Families must pay monthly premiums to buy health insurance coverage. They also must budget for the plan’s deductible (the amount you must pay before the plan starts covering some of your health care costs). And they must pay coinsurance on factor purchases (the percentage of the cost you must pay out-of-pocket [OOP], which may vary from 10% to 40%). These expenses must be paid until families reach their out-of-pocket maximum for the year, after which the plan picks up all costs.2 For a family with a child with severe hemophilia, this means budgeting for as much as $18,000 out-of-pocket, often within the first three months of the year. Few families can afford this expense.

To help meet these OOP expenses, factor manufacturers offer financial assistance to patients using their product, with annual assistance limits varying between $12,000 and $20,000, depending on the company and the product. Assistance is typically offered in the form of a card, often referred to as a “copay card”, “copay coupon card” or “savings card.” The card is presented at the time of service—such as to the pharmacist when picking up factor. The pharmacist will process the prescription using your insurance information as the primary payer and the copay card information as the secondary payer.1

Patient assistance programs are a godsend for families trying to make ends meet. So what’s the problem?

Insurers view these programs negatively, as a marketing tool for pharmaceutical companies to entice consumers to select more expensive brand-name drugs instead of lower-cost generic versions. This viewpoint may be valid for some drugs, but it doesn’t apply to factor or emicizumab, because there are no lower-cost generic forms of either type of drug. Insurance companies selling commercial insurance may also offer employers “cost savings” programs which thwart the use of patient assistance programs. And employers may opt to implement these programs, not realizing that, while saving money, they are also throwing some of their employees into financial ruin.

There are two insurance programs which target patient assistance:

Accumulator Adjuster Programs (AAP): The AAP are also known as copay accumulator programs. These insurance plan programs do not count a pharmaceutical manufacturer’s copay assistance payments towards the patient’s deductible or OOP maximum. The manufacturer copay card pays for prescriptions until the maximum value on the card is reached. Once it’s reached, your OOP costs begin counting toward your annual deductible and OOP maximum.

In a normal scenario involving copay assistance and no AAP in place, you would use the copay card to pay down your deductible and pay the coinsurance on your factor, both of which normally count toward the annual OOP maximum. Ideally, by the time the copay card is used up, you will have reached your OOP maximum, or be very close to it, and the insurance company will then pick up all costs for the year.

With an AAP in place, you would initially not see anything amiss, and the copay card would appear to be working as usual, and you would have no OOP costs for the first few factor shipments.

But then, usually around the third or fourth factor shipment, the copay card is used up and you are unexpectedly hit with the “copay surprise”—a bill for several thousand dollars. Only then do you  learns that your deductible and coinsurance have not been paid down by the copay card and you are now on the hook for several thousand dollars in costs each month until you reach your out-of-pocket maximum for the year.

Many hemophilia patients report not knowing their insurance plan implemented an AAP until they experienced the copay surprise. That’s because most health care plans are not up front about implementing an AAP and often use deceptive language, describing the AAP as a “benefit,” when, in fact, it is just the opposite.3

Thanks to advocacy efforts by nonprofit foundations like the NHF and HFA, sixteen states have banned AAPs, and a few other states have similar legislation in the works. Because of pushback on AAPs, insurance companies over the last few years have been switching to a different type of program to limit copay assistance, called a copay maximizer.

Next week: Copay maximizers, and more

  1. Some programs have restrictions, such as income limits, on who may qualify for their program. Assistance in meeting OOP expenses may also be covered by private organizations.
  2. Some plans, usually HMO plans, may have no deductible or coinsurance. Most commercial health insurance plans have both an annual deductible and coinsurance.
  3. BlueCross BlueShield of Texas calls it “Coupons for Individual Plan Members Only. ”CVS Caremark calls it “True Accumulation.” Express Scripts calls it “Out of Pocket Protection.” United Healthcare calls this “Coupon Adjustment: Benefit Plan Protection.”

Stunning Breakthrough: Hemgenix

Last week we shared an essay by Paul Clement about the approval for gene therapy for hemophilia A, approved only in Europe, and asked, when for the US?

While that question is still valid for hemophilia A, the stunning news this week was that gene therapy–at long last—is approved, for hemophilia B!

The news straight from CSL Behring: “This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion.”

The news was so startling, it made front page on CNN.com. But I suspect not for the scientific reason but for the economic reason: it comes with a $3.5 million price tag, making it the most expensive drug on earth currently.

Hemophilia Economics 101

While high prices are nothing new in hemophilia—factor therapy has always been among the world’s most expensive drugs—the sticker price was shocking to many. So many people have asked me through the years when is the price of factor going to come down, as if it were a high-tech consumer item like camcorders, Walkmans or DVD players. Remember those? They get mass produced, offshored, and millions upon millions of consumers buy them, which eventually drives the price down. And don’t forget competition. Basic supply and demand.

Hemophilia drugs are nothing like that. There are many factors that determine price but here are three: the research and development (R&D) that was spent to create the drug; the finite marketplace; and whether insurance will cover the cost.

R&D for drugs such as Roctavian, the brand name of BioMarin Pharmaceutical’s gene therapy product approved in Europe for hemophilia A, and Hemgenix, the brand name of CSL Behring’s gene therapy product approved by the U.S. FDA for hemophilia B, can surge to the hundreds of millions, if not billions, of dollars. The money needs to be recouped, and reinvested in the company, and to investors.  

The smaller the target audience, the higher the price. How can you recoup the R&D with such a small consumer audience as hemophilia B? In the U.S., there are approximately 20,000 with hemophilia, of which about 15% have hemophilia B. Not everyone of these patients will want gene therapy; not everyone can afford it.

By afford it, I mean have insurance cover it, which is the final piece of the pricing puzzle. Who will pay the $3.5 million per patient? State Medicaid plans? Commercial insurance? What if a patient on Blue Cross Blue Shield is approved, gets the gene therapy, has it reimbursed, but the following year switches plans? How does this benefit the bottom line at BCBS? Will insurance companies say no to gene therapy based on these concerns?

Advocacy is Key

This is where our decades of strong advocacy in the hemophilia community will make a difference. In a way, we’ve been preparing for this moment our whole lives. While the new drugs are not being touted as a cure, those of us old enough remember the slogan “A Cure by 2000!” We have fought for compensation for those infected by HIV and hepatitis from unsafe blood products. We fought for the new recombinant drugs, when insurance denied us. We fought for longer half-life drugs, for prophy, for bi-specific antibody products. All of these came with higher price tags, and eventually we prevailed.

And now?

We will all need to be educated about this new gene therapy, and how to approach our insurance companies, if we want it. As we have been preaching since 2005, when everything changed in insurance for hemophilia, you need to learn to speak the insurance company’s language; debate with them in a way they are used to; work with your healthcare team; stand with your state hemophilia group.

There are so many excellent products available to treat hemophilia, will insurance companies use this to deny gene therapy? At this point, no one knows, but we do know we need to get prepared. Why?

BioMarin is actively working on getting Rotavian approved for hemophilia A in the US. And that will impact thousands more in our community. How the insurance reimbursement of Hemgenix plays out could be a harbinger of things to come.

Read CSL Behring’s press release here.

Hemophilia Gene Therapy—is the US Next?

Paul Clement

Last week we discussed Roctavian, the brand name of BioMarin Pharmaceutical’s gene therapy product, valoctocogene roxaparvovec, to treat patients with severe hemophilia A, and the European Commission’s August 24, 2022, conditional marketing authorization for the therapy. Two big questions on everyone’s mind are: when will it be approved in the US and what will it cost?

US Approval Soon?

BioMarin submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market Roctavian back in 2019. In August 2020, the FDA responded by issuing a Complete Response Letter (CRL) to BioMarin, delaying their approval request and requiring two more years of additional safety and efficacy data from the company’s Phase 3 GENEr8-1 clinical trial.

Why did the FDA delay approval of BioMarin’s gene therapy? Its primary concern was the trend in clinical trial data showing decreasing efficacy of Roctavian over time, which could potentially render the therapy ineffective after several years.

At the end of September, BioMarin resubmitted its BLA for Roctavian with the requested additional data, and in a press release, announced that the FDA had accepted its resubmission of the BLA on October 12, 2022. Similar to the therapy’s conditional approval in Europe, the BLA resubmission includes a proposed long-term extension study to follow all trial participants for up to 15 years, plus two post-approval registry studies to follow patients dosed in a real-world setting.

According to BioMarin, BLA resubmissions are typically are followed by a six-month review process. However, the company anticipates that an additional three months of review may be necessary to review the new data—bringing the approval date to sometime in mid-2023. The approval of Roctavian is likely to proceed fairly rapidly: the FDA had previously granted Roctavian Breakthrough Therapy as well as Regenerative Medicine Advanced Therapy designations, both FDA programs designed to speed up the development and review process of therapies. And Roctavian also received an orphan drug designation from the FDA, granting it seven years of market exclusivity after approval. If approved, Roctavian would be the first commercially-available gene therapy in the U.S. for the treatment of severe hemophilia A.

How Much Will It Cost?

This is the million dollar question. Cell and gene therapies are extraordinarily expensive, ranging in cost from $373,000 (Yescarta, a cell therapy for lymphoma) to $2.8 million (Zynteglo, a cell therapy for beta-thalassemia). Pharmaceutical companies would like a one-time payment for the therapy up front, but health insurance companies balk at the high cost, citing concerns about efficacy (what if it does not work?), durability (how long will it last?) and patient mobility (why should we pay for a therapy that may last a lifetime, when the patient is likely to have a policy with us only three to six years?).

In response to these concerns and “failure to launch” for several gene therapies in Europe due to their high cost, pharmaceutical and health insurance companies have been exploring 16 different reimbursement models to make these expensive therapies more palatable to both parties. Two models stand out: the annuity model in which insurers make payments in installments over time; and the outcomes/milestone-based contract model in which the payment amount is adjusted depending on whether a pre-specified health outcome is achieved (i.e., the patient’s factor level will remain above a certain level for a certain number of years) if the outcome is not met, the pharmaceutical company might provide large rebates for patients that fail to respond to a therapy in a predetermined way). Both of these payment models may also be combined, in which an outcome-based contract with the manufacturer is connected to an annuity payment for the therapy, contingent on a positive health outcome.

BioMarin expects Roctavian’s list price in Europe to be roughly $1.5 million, after all discounts. They are currently in payment negotiations with Germany and will then move to France, Italy, and Spain, and then to other countries. (The healthcare systems in France, Germany, Italy, Spain and England are predominantly single-payer systems, with public health insurance covering either the entire, or the vast majority of the population, making payment negotiations easier than in the highly fragmented health insurance industry in the US). In Europe, BioMarin is negotiating outcomes-based agreements, with the goal of guarding against the risk of a “non-response” to treatment for at least five to eight years.

What about the cost in the US? BioMarin has not set a price for Roctavian in the US, but has suggested it will be between $2 and $3 million. How this new therapy will be greeted by health insurance industry in the US remains to be seen. So far, the effect of cell and gene therapies on the US health insurance landscape has been minimal, because there are currently only a handful of products licensed in the US. However, major changes are on the horizon: there are about 3,000 cell and gene therapy therapies in the pipeline, and by 2025, the FDA predicts they will be approving between 10 and 20 cell and gene therapy products per year. And these therapies will require the adoption of new payment models if they are to reach  consumers.

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