Solvadi, the new Hepatitis C drug that costs $80,000 or more for a three month course of treatment, is producing an interesting and instructive set of case studies of implicit and explicit decision rules as to who gets the drug. There is a limited supply of Solvadi and payers are extraordinarily reluctant to pay $80,000 to everyone who has Hepatitis C as that would destroy their cash flow for the year. This statement applies to for-profit insurers, it applies to non-profit insurers, and it applies to governmental programs such as Medicaid and CHIP. So the question that is raised, either explcity or implicitly, is who gets the drug? There are several different methods that could determine this result.
The first one is a free for all for a limited supply of doses. Anyone can get the drug if they are within the first X number of people on the list as that is the number of doses the payer can afford to buy this year. I have not seen any explicit cases of list based distribution as this type of system is rife with lawsuit potential and absolutely horrendous news stories. It is also inefficient as there are several stages of the disease, and some people who would be treated on the list method would be at a stage where their health and quality of life had not been compromised while people with few remaining good options would be left waiting. Part of the control functionality could be placing Solvadi on the highest tier of drugs so that there would be a $5,000 or $6,250 (max allowable) out of pocket co-pay. It would be a scheme targeted for the rich, well insured, and/or connected.
The second method is a prioritization method based on clinical indicators. Anyone with Hep-C could get the drug and see improvement, but the drug would be reserved for those where Hep-C has already caused significant liver damage. At this point, the goal is damage limitation via a late arriving cure instead of damage prevention. From a public health point of view, this is fixing the water damage in the ceiling instead of being able to take care of the roof during the sunny season of reasonalbe health. The upside is that we know the drug is being effectively targeted. The major downside is that we also know that people who are currently in okay shape will go to significantly worse shape in the future. It is a temporary solution until there are either competitors on the market, public shaming brings down the price, or fear of regulatory action brings down the price.
The third method could be the most controversial. It is a modification of the second method in that it seeks to identify high priority needs. The diffrence is that it is a hybrid of personal health and public health. The goal of the third method of distributing very limited and expensive drugs would be to attempt to distribute to people who are both sick and highly likely to infect future individuals. The goal is to minimize future infections and thus future demands for Solvadi.
How would this be done?
We know that the primary infection transmission profile of Hepatitis C is from blood to blood contact. It takes effort and personal contact to spread Hep-C.
In the United States, that typically means drugs being injected by shared, uncleaned needles. There are other modes including household blood to blood exchange such as sharing an unsterilized razor blade, but the most common is drug usage. The goal would be to identify people who are in high risk behavioral pools that include significant number of non-infected individuals and then treat them aggressively. The rule would favor individuals who are the only member of a high risk behavioral risk pool who is currently infected as they would be the most likely source of multiple future infections.
However, if an individual is a member of a high risk behavioral pool where a very large proportion of the membership is also infected, treatment in the public health infection transmission minimiziation mode would not be effective for two reasons. First, there is a reasonable risk of reinfection. Secondly, any infections that are averted by treating a high risk for tranmission individual would most likely be “replaced” by transmitted infections from other sick members of the pool to other healthy members of the pool. People who are in a high risk pool that is entirely infected would not be candidates for infection transmission chain breaking doses. For instance, a husband and wife who are both HEP-C positive from a bad tatoo years ago but are otherwise in pretty decent health AND not engaged in any other high risk behaviors have minimal infection transmission risk. Under this schema, they are not good candidates for Solvadi as the benefits would only acrue to them and not to any potential future infections averted. If their health went downhill, that is another story.
This schema is based on the studies of how HIV is transmitted in Africa. The studies showed that there were a few key players who could block most infection routes. Long distance truck drivers who frequently saw prostitutes in multiple cities acted as conductors of the disease between otherwise disconnected clusters. Prostitutes acted as local mixers where there were numerous infection opportunities. If there are a large number of infection opportunities, then the laws of disease transmission probability come into play. The research showed that targetted condom distribution, education and treatment to long haul truck drivers and prostitutes would often be the most efficient way to reduce future infections using solely medical resources. (Getting women out of prostitution through improved economic stability would also be a good approach but that is another story for another day.) The insight was that most diseases are social diseases so disrupting a few key nodes of the social network graph of transmission would produce massive results for relatively low investment.
The downside to the hybrid personal health/public health transmission attack methodology is two fold. The first is political. Expensive, high value, high efficiency drugs would be given to THOSE PEOPLE instead of Good Middle and Upper Middle Class People. THEY DON’T DESERVE IT. Specifically a good proportion of these drugs would be held for drug users. That is a great way to get a crab-bucket politics shit-storm. Secondly, it would require a national coordinating entity with significant participation of most major payers and providers. Some method would be needed to determine who would be a good candidate for both personal and public health purposes. That can’t be done well if some insurers will buy Solvadi for anyone who can meet the $6,250 cost-sharing requirement for the Tier 99 drug, and others engage in honest public health evaluation. As it is, this schema would most likely initially be paid for disproportionally by Medicaid, so new resources would be needed. Again, this is partially a technical problem (coordination) and partially a political problem (death panels vs. technocratic public health measures that don’t prioritize the privileged).
My guess is that most payers for at least the two years will adapt the second method; Solvadi prioritization based on clinical indicators. This means there will be more future infections but from every payer’s point of view, that future infection is most likely someone else’s problem.