Costs, Coverage Issues Spur Black Market for Fertility Meds

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By Dana A. Elfin

The high cost of fertility drugs and treatment and spotty insurance coverage is driving some patients to buy others’ leftover fertility medications.

The drugs cost up to $5,000 per cycle of in-vitro fertility (IVF) treatment, and many patients undergo multiple cycles. Drug costs can run even higher for older patients who might require higher dosages to stimulate egg production.

The lack of insurance coverage for infertility treatments and the high out-of-pocket costs for fertility medications mean patients often struggle to handle the costs. Basic IVF can range from $10,000 to $15,000 per cycle, and these numbers don’t include the cost of medications needed to stimulate egg production.

IVF is a procedure in which sperm are put in a special dish with unfertilized eggs to achieve fertilization outside the body. IUI, another assisted reproductive technology, involves placing sperm inside a woman’s uterus to boost the chances of fertilization.

Although some makers of fertility drugs like EMD Serono Inc. have programs to help patients afford their medications, that’s not preventing some patients from taking matters into their own hands. Postings on the fertility-related website freegaragesale.org illustrate what’s happening on the Internet regarding fertility drugs.

Internet Postings

One recent ad offers to sell leftovers of the Merck & Co. injectable fertility drug Follistim (follitropin beta) expiring in July for $300 in cash or best offer.

“Meds were super successful for me—20 eggs frozen at once!” the ad said, promising all the medications were properly refrigerated.

In another posting, a person in Houston is “looking for a trigger shot such as ovidrel” and is “willing to pay for shipping as well.” EMD Serono makes the injectable gonadotropin hormone Ovidrel.

Lack of Insurance

“This kind of thing is what patients are driven to when so few have insurance coverage,” Sean B. Tipton, chief advocacy and policy officer at the American Society for Reproductive Medicine, told Bloomberg Law June 8.

“The entire issue is yet another example of how out-of-pocket costs are impacted by the lack of insurance coverage for infertility treatments,” Andy Schwartz, director of public relations for RESOLVE: The National Infertility Association, told Bloomberg Law.

“A big issue in the fertility community is inadequate coverage and reimbursement for needed medicines,” Libby Baney, principal at Faegre Baker Daniels Consulting and senior advisor to Alliance for Safe Online Pharmacies (ASOP) Global, told Bloomberg Law June 20. “Combine that with the duration of treatment and out-of-pocket costs, and you can see how patients could be attracted to websites and online sellers offering deals.” ASOP Global is a nonprofit dedicated to protecting patient safety online.

Only 15 states mandate insurance coverage for fertility treatments. Those states are Arkansas, California, Connecticut, Hawaii, Illinois, Louisiana, Maryland, Massachusetts, Montana, New Jersey, New York, Ohio, Rhode Island, Texas and West Virginia. But even those state laws contain exemptions.

Bloomberg Law sought comment on the coverage issue from America’s Health Insurance Plans, the national trade association for the health insurance industry, but the group didn’t respond.

Baney said more patients are buying drugs on the Internet as patients pay more out of pocket and become more tech savvy.

“While we don’t have fertility-specific data, we do know that approximately 33 percent of Americans have purchased prescription drugs from an online pharmacy for themselves or someone under their care,” she said. “Furthermore, 21 percent of individuals have or would purchase specialty medications, including those for fertility or birth control,” she said, citing data come from the ASOP Global May 2017 Online Pharmacy Consumer Behavior and Perception Survey.

Gonadotropins, the most expensive fertility drugs, stimulate the ovaries to produce eggs to increase the odds of conceiving with an IVF or IUI (iIntrauterine insemination) procedure.

Major players in the human chorionic gonadotropin market include Merck KGaA subsidiary EMD Serono, Merck & Co., Bristol Myers Squibb Co., Ferring B.V., Fresenius Kabi USA LLC.

And the global market for gonadotropins is growing; the market was valued at $353 million in 2016 and likely will hit $612 million by 2025, with an annual growth projected rate of 7.1 percent, according to a Brisk Insights Inc. report.

Patient Assistance Programs

Bloomberg Law contacted several fertility drug makers about whether they offer patient assistance programs to patients who are struggling to afford their fertility medications.

EMD Serono is “dedicated to increasing access and opportunities for those looking to start a family by offering educational, emotional and financial support,” company spokeswoman Melissa Beglin told Bloomberg Law June 20. “Our Fertility Lifelines website provides information about infertility, including options/resources, as well as fertility medication savings through programs like Compassionate Care, Compassionate Corps and the Go Direct to Savings for eligible patients living with infertility.”

EMD Serono makes the injectable gonadotropin hormones Gonal-f (follitropin alfa) and Ovidrel; as well as Cetrotide (cetrorelix acetate for injection), another type of injectable hormone.

Merck & Co. doesn’t have a patient assistance program for its Follistim fertility product, spokesperson Pamela Eisele told Bloomberg Law.

And Ferring Pharmaceuticals Inc., which makes the injectable hormones Menopur (menotropins for injection) and Novarel (chorionic gonadotropin for injection), didn’t respond to several attempts to contact it.

Safety Concerns

Safety concerns come with buying drugs from individuals online or unverified online pharmacies. Buyers don’t know whether the fertility drugs have been stored properly. Many of these medications require refrigeration.

“The problem is, especially for the fertility patients who often need medicines that are highly sensitive and/or need to be kept in cold-chain, is that you can’t tell by just looking at the medicine sold online if it will work or even contain dangerous contaminants,” Baney said. “It’s a big risk.”

An unbroken cold chain refers to an uninterrupted supply chain that’s temperature-controlled and refrigerated.

Illegal online sellers have been found to sell counterfeit products and/or to repackage and resell substandard and expired medicines, Baney said. Counterfeiters will also create labels and packaging for the goods in an effort to mimic legitimate medicines, she said.

“It may be harmful for women to purchase and use fertility drugs that were not handled and stored correctly and that were not specifically prescribed for them by their health-care provider,” Food and Drug Administration press officer Theresa Eisenman told Bloomberg Law. “The FDA recommends only obtaining fertility and all other medicines from licensed pharmacies located in the United States. The risks of purchasing medications from sources other than a licensed pharmacy outweigh any potential cost savings.”

The FDA has also warned consumers about the potential pitfalls of buying drugs online and offers a guide for consumer safety, she said.

Although Bloomberg Law could not find any documented cases of harm from purchasing fertility medications on line, this past May the FDA posted a safety alert about several lots of Gonal-f that had been stolen in Italy. The agency advised health-care professionals and patients to check Gonal-f products for possible tampering before use and advised consumers to make purchases only through licensed wholesale distributors and pharmacies.

Eisenman didn’t respond to questions regarding enforcement issues and whether the government has ever gone after individuals selling leftover fertility medications over the Internet. Baney said the FDA hasn’t taken legal action against individuals importing prescription drugs via the Internet.

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