The executive director of the Health Insurance Administration (ASES), Jorge Galva, once again insisted that Senate Bill 1658 —which seeks to prohibit the medical criteria from being modified by insurers regarding prescription drugs— represents a “high risk ”to the finances of the Vital Plan as it was presented, especially when an increase in the cost of so-called“ orphan drugs ”(OD) is emerging.
ODs are new specialty drugs, approved by the Federal Food and Drug Administration (FDA), used for chronic diseases, and priced at high prices. In fact, this week the different components of health on the Island, at the request of the Secretary of Health, Lorenzo González, will discuss the recent approval of the plasma infusion treatment and the administration of Remdesivir to hospitalized patients and positive for Covid-19. These cost $ 750 and $ 3,200, respectively, for each dose.
The situation with the management of the price of plasma and Remdesivir is of concern to the government, since the indigent group insured in the Vital Plan is around 1.4 million beneficiaries, almost half of the population in Puerto Rico.
Project 1658 was approved by the Legislative Assembly, but until yesterday afternoon it was in the process of being sent to La Fortaleza for the signature of Governor Wanda Vázquez, who announced it in mid-June as a measure of justice for patients. and doctors.
The position of ASES has raised questions in the patient defense groups, and the Association of Insurance Companies (Acodese) has indicated that it recognizes the positive intention of the measure, but warns that there are already mechanisms to handle the approval in the office of recipes. It also indicates that the approved amendments could create other situations.
THE SPOKESMAN knew that this week the meetings between ASES and legislators on the subject should arise.
One of the provisions of the bill is that it orders insurers to evaluate and determine the approval of a prescription drug in or before 48 hours.
Given the fact that the Vital Plan has a coordinated care model, Galva defended the current criteria for pre-authorization (PA) of prescriptions and said that “they are established to ensure diagnosis and treatment by the specialist in charge of the patient and that the medicine high cost and highly specialized is used only in those patients who meet the criteria of clinical studies that gave it approval by the FDA.
In cases where there is more than one therapeutic alternative for a disease, he indicated that only one high-cost drug is included.
Changes “cannot be postponed”
At first, ASES favored the senatorial measure, but later requested that the bill be returned to the Legislature for technical changes that it defined as “cannot be postponed.”
Galva’s differences and concerns with the piece are explained in detail in a six-page circular letter issued on Friday to various entities and to which THE SPOKESMAN had access. It was directed to Coordinated Health Care Organizations (MCO) contracted under the Vital Plan, the Pharmacy Benefit Manager (PBM), the Pharmacy Program Manager (PPA), pharmacies, Primary Medical Groups (GMP), primary physicians and participating providers.
Galva stressed that even though “the ASES emphasizes that all the efforts of the current administration are focused on ensuring access to high-quality services”, it is important that “when making decisions, they are based on empirical evidence and sustained in the best administrative, financial and health practices ”.
As a starting point, Galva stated that “the measure was not accompanied by an actuarial study that illustrated the highly material prospective effect of certain provisions included. Furthermore, and very unfortunately, the project was not accompanied by an economic allocation that will be essential to face the effects of the availability in the current market of certain high-cost drugs.
The official insisted that this analysis was what led the agency to propose a revision of the legislative piece. “The categorical risks that they will have in the finances of the Vital Plan, as well as in the programs for the benefit of the patient that will be affected by an unsustainable rise in costs, must be taken into account and properly managed,” Galva added in the circular letter. He added that the legislative project did not contemplate the recommendations of the ASES.
Iraelia Pernas, executive director of Acodese, said yesterday that an example of the concerns are the drugs that cannot be divided and then are found to interact negatively with others that the patient has. “If at the end of the day the patient did not have the right to medicine, they have to pay – in full – to the pharmacy, and then who pays the insurer?”
According to the approved project, there is an “obligation to offer immediate temporary coverage for an initial prescription of the prescription drug during the process of requesting medical exceptions and until (the insurance entity) notifies in writing its final determination, when the doctor or professional of the health that issued the prescription must state in writing that the prescription drug requested is medically necessary ”. This would be done to guarantee access to treatment as soon as the certification arrives.
Steady rise in cost
According to ASES, in 2014 the investment for the payment of prescription drugs represented 19% or $ 487 million of the total budget of the agency for the Vital Plan. In 2016, the total investment in health services was $ 2.8 billion and 28% or $ 626 million was for drugs. Already in 2019 the figure for prescription drugs reached $ 710 million.
Galva explained that in addition to the administrative efforts to manage costs and expenses, the Fiscal Control Board urged in 2017 more measures to reduce costs and the analysis led “to include, exclude or exchange more cost-effective drugs. From there came the Formulary of Covered Drugs (FMC), which is the official list of preferred and non-preferred drugs that are included in Vital’s coverage, and the List of Drugs by Exception (LME), which is a supplementary list of drugs that doctors can use as long as their patients have exhausted all the options available at the FMC. “
He mentioned that if a patient needs a drug that is not in the FMC or LME and that is not excluded by federal mandate, “his doctor can request it only through the Exception Process, sending the clinical justification of medical necessity and the evidence required for its processing ”. She noted that ASES has never deviated from this closed form structure and stated that it is also an integral part of the State Medicaid Plan.
The ASES head added that last year 51% or $ 360.5 million of everything paid for prescriptions corresponded to medications for chronic conditions such as multiple sclerosis, rheumatoid arthritis, cancer, hemophilia and pulmonary arterial hypertension, among others.
Referring to ODs, Galva pointed out that they will constitute 44% of all drugs approved by the FDA in 2020, which already means that there will be higher costs to attend different chronic treatments.