Vaccination programs are based on the old adage that an ounce of prevention is worth a pound of cure. Since 2007 Canada has had a vaccination program for the Human Papillomavirus (HPV) administered to girls, although the age of vaccination varies by province: Grade 5 in Alberta and Grade 8 (with catch up until Grade 12 for those not previously vaccinated) in Ontario.
Now many provinces are wrestling with the decision about whether to expand the program to also vaccinate boys.
HPV and cancer
HPV is one of the most common sexually transmitted infections, according to the Public Health Agency of Canada. It is estimated that more than 75% of Canadians will have at least one HPV infection in their lifetime. HPV causes non-genital and genital warts as well as cancers of the cervix, oropharynx (mouth and throat), anus, penis and vulva.
The strongest association between HPV infection and cancer exists for cervical cancer. Two types of HPV (16 and 18) are responsible for approximately 70% of cervical cancers. Every year in Ontario more than 600 women are diagnosed with cervical cancer and 150 women die from the disease.
There are now vaccines for HPV that reduce the rates of persistent infection leading to cervical cancer, and it is this benefit that led to the 2007 roll out of vaccination programs across Canada.
Why immunize boys?
Recently, pressure has begun to mount for governments to cover the HPV vaccine for boys. This move is supported by a statement from the National Advisory Committee on Immunization (NACI), recommending that there is good evidence for the use of the vaccine for boys and men age 9 to 26 years. NACI goes on to say that governments should consider a range of factors when deciding whether to add males to the female-only vaccination programs.
There are two primary reasons to consider expansion of the program.
The first is that herd immunity (the level of immunization reached that results in overall population protection even for those who are not immunized) is dependent on achieving a certain rate of vaccination of girls. The programs are designed with a 90% target for vaccinations, and while rising, the current rates are around 70% in Ontario and 61% in Alberta. Since these rates do not reach the target needed to achieve herd immunity, vaccinating boys could have additional benefit.
Dr. Shelley Deeks, Medical Director, Immunization and Vaccine-Preventable Diseases at Public Health Ontario, points out that while 90% is the target, the programs are still effective at lower rates. “There is emerging evidence that with 70% immunizations rates for girls, the programs in the US and Australia are already achieving herd immunity as shown by a dramatic decline in genital warts” she says.
The second is the concern that a high-risk subgroup, men who have sex with men, receive limited benefit from the current program. This population is at risk for less common cancers, including throat, anal and penile cancers that may be related to HPV infection.
“They are mostly excluded from the benefit of herd immunity created by the female based vaccination programs” says Deeks. Since the vaccine’s potential is expected to be greatest when administered before an adolescent becomes sexually active, “it difficult to protect this population without a policy of broad vaccination of all male adolescents since young men are unlikely to self-identify prior to sexual onset”.
Not an inexpensive decision
Despite the above two reasons and the NACI recommendations, covering boys with HPV vaccine is not a straightforward decision. A full course of the vaccine costs between $450 and $500 in Canada. This cost was initially offset by a one time, five-year federal government investment of $300 million dollars to get the initiative underway.
Models developed using demographic and disease prevalence data showed it is far more cost effective to reduce the incidence of cervical cancer through a mass vaccination program that targets girls. The models look at the impact of immunization on the rates of cervical cancer. The models shows that while immunizing girls has a significant impact on cervical cancer rates, with a 63% reduction, doubling costs by immunizing boys only achieves a further reduction of 4% in cancer rates.
However, the models are based on the assumption that 90% of girls are immunized, lower than Ontario’s vaccination rate of 71%. Deeks argues that since the cost effectiveness of vaccinating boys isn’t as well established as it is for girls, perhaps programs should focus on trying to “increase the vaccination rates of girls before adding boys.”
The findings of a cost effectiveness analysis published in the British Medical Journal in 2009 show that the estimated cost-effectiveness of vaccine programs targeting girls to reduce cervical cancer rates is around $50,000 per quality-adjusted life-year gained (QALY). In contrast, conservative estimates of adding boys to the mix is said to cost approximately $300,000 per QALY gained.
Such variation in the cost-benefit of preventive measures is not unique to this vaccination program. A landmark American study published in 1995 reviewed 500 different ‘life-saving’ interventions and found major differences in cost effectiveness, ranging from $40 for an exercise stress test to detect heart disease to $34 billion for screening newborns for sickle cell disease.
The ethics of considering cost
All health care systems ration services. Some ration by income, some ration by need. Some jurisdictions have chosen to set thresholds for funding new treatments. For example, the UK has set a ceiling price that marks the top price that they are willing to pay, and it is measured by the cost to buy one quality-adjusted life-year. These thresholds for cost effectiveness alone predict the nature of 82% of the funding recommendations made by the National Institute for Health and Care Excellence in the UK.
Thresholds provide more clarity and transparency about what governments will fund since they are upfront about limits on one hand, but at the same time, they do allow limited flexibility in buying some very expensive interventions. Some argue that pricing strategies for pharmaceutical companies respond to thresholds, therefore helping to keep costs lower. However, others argue that thresholds can drive the costs of certain cheaper drugs higher because companies price their treatment to meet the ceiling for payment.
In Canada, we don’t set explicit thresholds, “Thresholds dichotomize a scale into cost-effective versus not,” says Dr. Murray Krahn the Director of the Toronto Health Economics and Technology Assessment Collaborative. “You must have a scale that has some meaning to it, but refusing to commit to an explicit threshold means that we are implicitly adopting a kind of continuous cost-effectiveness scale.”
Krahn explains that cost effectiveness is one attribute among others being considered in a decision-making framework. “Cost effectiveness tells you whether or not you are getting a good deal, or perhaps spending too much, but that is just one dimension” he says.
Decision making… beyond cost
While considerations of cost and the related ethical issues are certainly important, Krahn says there is also broad agreement that health policy decision making in Canada’s publicly-funded health care system are as much driven by other considerations as by economic estimations of value for money.
Other societal factors that might be weighed include: “vaccine fear”; feminist concerns (such as whether or not it is equitable for women to bear the full responsibility for the consequences of sex); the health needs of the gay community; the policy principle of gender neutrality and perceptions about the role of the pharmaceutical industry.
Krahn maintains that cost should be just one of three considerations when making resource allocation decisions in health care. He says “first, there is consideration of the evidence that vaccinating boys improves health outcomes for anyone, and whether it is safe. The second question is, whether it’s cost effective. If you are spending some money, the denominator will be how much benefit will that additional spend provide? The third consideration is how does society feel about this decision?”
Prospects for expanding the HPV vaccine to boys
It is perhaps due to these many other factors that, despite the hefty cost of adding boys to the program, Alberta and PEI have chosen to expand their coverage of HPV vaccination to boys and most other provinces are finding themselves under pressure to consider it.
HPV vaccination illustrates the complexity of decision making regarding the public coverage of interventions in health care. Decisions regarding the type of vaccination program to offer are value laden, heavy with controversy and require complicated choices. This debate helps to demonstrate the need for discussion that brings greater transparency to the conflicts that arise between the concepts of individual patient rights, public and political views, and evidence-based decisions on where to best spend public dollars.
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It seems idiotic that this is even a question? “should we treat boys health the same as girls health” hmmmm???? why should a vaccination only be geared towards girls when it also effects boys? just another example of the feminist PC dump Canada has become in recent years.
Those, who don’t agree that boys or even girls should be vaccinated, have to see once the sufferings, the emotional and physical pain, the shame of the patients with this disease. I’m pretty sure they will revise their opinion. And if you think you will never catch it- “Never tell never”
I am nurse, and in my practice I have seen many cases of genital warts in young males who needed to undergo several painful treatments. I have a daughter and a son, my daughter is protected by the vaccine, but I want my son to be protected too. From my perspective, it is very important to vaccinate girls and boys, to prevent this terrible disease. If the government will not subsidize the vaccine for boys until my son will be 12 years old, I will pay for it, in order to vaccinate him, because I have seen the suffering and the shame of the young patients who needed to undergo the treatment.
From personal experience, the cost of the vaccine, including the small likelihood of vaccine injury, is minimal compared to the costs involved financially, for the patient and medical system, and emotionally, for the patient and their caregivers, when there are 8 weeks of specialist visits and tests leading up to a 7 week treatment period(of daily radiation with or without chemo support) and a 4-12 month convalescent period. My daughter is already vaccinated, my son will be in short order. The causes aren’t new, the technology has changed to allow us to find the causes and the vaccine. If the only way to ensure your child won’t be exposed in their life time is to prevent them from all sexual contact until they find a monogamous life partner with parents who have done likewise(have to say that this is virtually impossible and against basic human instinct), why would you not do what you can with the measures at your disposal.
It is unfortunate that the organizations responsible for “looking out for our safety and well being” appear to be compromised by their relationship with pharmaceutical companies, but I’m not sure that completely severing all possible conflict of interest appearances would make the naysayers any more likely to be supportive. Sadly, it is easier to believe in inherent evil intent.
As a man who has had oropharynx cancer, I feel it is imperative to have the shot for boys. Cost should not be an issue considering the cost of cancer treatment later.
On a very basic level, kids understand that they would benefit from it and they appreciates the opportunity of having some additional peace of mind. Being young is already a minefield. I don’t think it need be any more difficult than it has to be. The health benefit cannot be overstated. One episode of the kind preventable by the HPV vaccine could scar a kid for life. Simply say yes and make it more affordable for governments.
It makes you wonder if this fact that immunization policy feeds the idea that society values female lives more than they do male ones. With the recent kidnapping of the Boko Haram of the 200+ girls and the worldwide public outcry – where were these voices up until a few weeks ago when they were killing boys in considerable numbers? It almost sounds like the studies were designed to exclude boys in the first place and reduce costs. Would the cost of vaccine drop dramatically if it was purchased in greater quantities. Also it appears that the figure of getting 90% of the girls vaccinated is unrealistic considering the hurdles that have to be crossed (misinformation etc) to increased this figure from where it is now. It would appear that these comparative costs are based on an almost completed vaccinated girl population that is impossible. Would it now make sense to bite the bullet increased the male population as much as possible now that the 90% goal is unreachable instead of bandying around false numbers, as this is after all a communicable disease?
There is no controversy regarding this matter among those who have made a point of thoroughly reading the literature on HPV – it is critical for boys to be offered the HPV vaccine!
Indeed, the provinces who continue to delay complying with overwhelming medical advice in this regard risk being sued by adult males, vaccinated too late or not at all, who eventually develop cancer – yes, a number of cancers in males are caused by HPV.
Read the HPV literature – most abstracts are available via the free online service known as PubMed.
Thank you for your response. You are correct, the reference has been removed and replaced with a 2009 BMJ Article which references cost effectiveness for the vaccine against cervical cancers caused by HPV 16 and 18. “Under assumptions of 75% vaccination coverage and complete, lifelong vaccine protection, routine HPV vaccination of 12 year old girls who are screened using cytology (HPV DNA testing for triage) at current rates in adulthood was associated with an incremental cost effectiveness ratio of $40 310 per QALY gained compared with screening alone when including only benefits related to cervical disease (table 2⇓). Adding 12 year old boys to the vaccination programme provided benefits for higher costs and had a cost effectiveness ratio of $290 290 per QALY compared with vaccinating girls only.”
Cost effectiveness analysis of including boys in a human papillomavirus vaccination programme in the United States
BMJ 2009; 339 doi: http://dx.doi.org/10.1136/bmj.b3884 (Published 8 October 2009)
Cite this as: BMJ 2009;339:b3884
I am the first to admit my knowledge of QALY, public health, and related issues is primitive at best, I do wonder about the ethics of NOT offering the vaccine to males, based on the following considerations:
1. since the infection with and transmission of HPV involves males more or less to the same extent as it does females (I assume) , it seems counterintuitive not to “break the chain” wherever links exists,
2. as noted, male to male transmission is de facto excluded by a female-only vaccination payment program,
3. Cervical cancer, which I understand is to a large extent the most costly effect of HPV infection (though I may be wrong about this), also has another direct cost: screening. If HPV prevalence were significantly reduced, then screening guidelines (i.e., Pap smears) would likely have to change, and that could have a significant positive benefit on costs, both in terms of healthcare system dollars and resources, and on patient acceptability (reduced frequency, less “blackmail-for-birth-control”, etc.
I’m not certain I have all the information I need to make a reasonable decision, but the current evidence and the potential for direct and indirect benefits tends to sway me toward supporting universal vaccination (within the demographic discussed).
A 2012 CMAJ article is linked as the source of the claim that “…conservative estimates of adding boys to the mix is said to cost approximately $300,000 per QALY gained.” That CMAJ article does not explicitly say anything about ICERs, QALYs, etc. Perhaps the link is incorrect?
The 2009 BMJ article (Kim and Goldie) cited earlier in the same paragraph DOES support that claim (Table 2), but only when cervival cancer is the only outcome considered in the cost-effectiveness of vaccinating boys. When other cancers in both sexes were added to the analysis, the ICERs were $114.510 to $164,580 per QALY depending on the vaccine efficacy assumption. When all HPV-related diseases in both sexes were considered, including genital warts, the range dropped to $90,870 to $123,940 per QALY.
All of those were much higher than comparable ICERs for vaccinating girls only, but much lower than $300,000 per QALY.
Informed consent to this vaccine should be looked into, as discussed in the 2012 study in Public Health Nursing titled “Ill-Informed Consent? A Content Analysis of Physical Risk Disclosure in School-Based HPV Vaccine Programs” which states,
“This review found important discrepancies in the accuracy, completeness, and consistency of information disclosed about HPV vaccine-related physical risks, with respect to both the nature and probability of risks. These discrepancies have a significant effect on the legal validity of the consent/authorization process.”
Of course, where do you think the girls get this from?…THE BOYS!!
Re: the NACI recommendation, I just want to note that eight out of the ten voting members of the NACI have direct and/or indirect conflicts of interest with to pharmaceutical companies, many of which manufacture vaccines.
Also, on the Public Health Agency of Canada website above, you will also see one of the members of NACI state that they are “Co Primary Investigator of the IMPACT Network – which is partially supported by grants from Industry (Novartis, GlaxoSmithKline, Sanofi)”
Why is the network that is supposed to be looking out for vaccine injury supported by grants from pharmaceutical companies that make vaccines? Isn’t that the fox guarding the hen house?
I feel the same that this should be a separate body. One without influence and money/power. For these reasons, I didn’t believe the literature as being clear and concise to make a decision for my daughter’s health. We discussed and chose not to go forward with this vaccination.