Are Insurance Companies’ Medication Directives Fiscally, Medically Questionable?

Insurance Company Medication Directives

Fiscally, as well as medically ‘questionable’?

Insurance companies have traditionally denied the accusation that their “behavior” represents the practice of medicine without a license, claiming they don’t prohibit care. Rather, they have claimed to be indicating the limits of their coverage. It is unclear if their medical directors are participants in the formulary process or simply figureheads. Now, insurers seem to deviate from that approach, actually promoting their preferred practices and medications directly to patients, independent of the safety or efficacy of those practices. In doing so, have they undermined and compromised the ability of practicing physicians to provide quality care? Such behavior includes contacting patients directly and instructing pharmacies to push medications they knew or should have known did not meet equivalency requirements or were documented as not equivalent and less safe.

Unnecessary gastrointestinal bleeds related to lack of effective gastroprotection clearly exemplify this issue. The MUCOSA study clearly documented twofold reduction of gastrointestinal events requiring hospitalization for individuals age 52 and older, contrasted with rules limiting access to those who have achieved age 65.^1,2

Prior requirement (for use of a COX-2 agent) for evidence of misadventure with or therapeutic response failure of two less safe (2% hospitalizations for gastrointestinal events per year) agents does not seem medically justifiable or fiscally responsible.

Promoting and substitution of components for a combination medication (e.g., Arthrotec), if they were clinically equivalent, might be acceptable—if the appropriate time course was observed. It’s not. The misoprostol component must be taken 20 minutes prior to the diclofenac component if gastroprotection is to be achieved. However, there is another problem. There are multiple classes of bioequivalence, not all of which actually require documentation of that bioequivalence. Further, there is a difference between chemical and clinical equivalence. Misoprostol, formulated as a component of Arthrotec, even given once per day, has been documented to reduce major gastrointestinal complications by 50%.^1,2 Separate administration of diclofenac and misoprostol at equivalent dose lacks that efficacy! Achieving a similar safety profile requires the misoprostol be taken at least three and, preferably, four times per day.³

Similarly, care is compromised by promoting use of alendronate (Fosamax), despite documentation that one in eight women with arthritis experience a 2 gram hemoglobin drop within three months of starting that medication, a complication not found with alternatives for treatment of osteoporosis.⁴ This appears not only medically irresponsible, but also does not appear to be cost effective from a fiscal perspective.

How are insurance company formularies derived? One hopes it’s not by individuals with the same training as the one who asked why Celebrex was prescribed for arthritis rather than an antidepressant. Given past insurance company demands that the indication for a prescribed treatment have FDA approval, it’s intriguing that use of Lyrica (approved for the indication) has been refused in favor of a medication that lacks FDA approval for that indication.

One wonders why these medically questionable and fiscally irresponsible decisions have been allowed to persist. Perhaps the insurance companies do not expect to be involved with specific patients long enough for the extra toxicity to manifest. One wonders if such behavior, which deprives compromised individuals of access to care, represents a violation of the Americans with Disabilities Act.

Sincerely,
Bruce Rothschild, MD
Professor of Medicine, Northeast Ohio
Medical University and Indiana Regional
Medical Center, Indiana, Pa.

References

1. de Melo Gomes JA. The safety of Arthrotec in patients with rheumatoid arthritis or osteoarthritis: An assessment of the upper gastrointestinal tract by endoscopy. Scand J Rheumatol Suppl. 1992;96:23–31.
2. Goldstein JL, Larson LR, Yamashita BD. Prevention of nonsteroidal anti-inflammatory drug-induced gastropathy: Clinical and economic implications of a single-tablet formulation of diclofenac/misoprostol. Am J Manag Care. 1998 May;4(5):687–697.
3. Silverstein FE, Graham DY, Senior JR, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995 Aug 15;123(4):241–249.
4. Rothschild BM, Helbling M. Is coadministration of alendronate and nonsteroidal antiinflammatory drugs an unacceptable risk? J Clin Rheumatol. 2002;8:288–290.